Author: Rachael Hansford

New real-world data for ONGENTYS®▼ (opicapone) released at the MDS

Posted on September 22, 2020 by - Parkinson’s Disease

New data presented 12-16 September at the MDS 2020 Virtual Congress further support the efficacy and tolerability of ONGENTYS® (opicapone) observed in pivotal Phase III studies. Opicapone is a once-daily catechol-O-methyltransferase (COMT) inhibitor, approved for the treatment of end-of-dose motor fluctuations in adult PD patients taking levodopa.

  • Data from OPTIPARK study demonstrated consistently low incidence of treatment-related adverse events in clinical practice from the third week onwards in Parkinson’s disease (PD) patients with motor fluctuations treated with opicapone (as an adjunct therapy to levodopa)1
  • Further evaluation of data from two large multinational trials (BIPARK-I and II) demonstrated opicapone’s potential for patients in the early stages of motor fluctuations and its capacity to reduce OFF-time when used as a first COMT add-on therapy to levodopDDCI2,3,4,5
  • Additional data from BIPARK-I and II showed that treatment with opicapone leads to a substantial reduction in morning OFF-time in PD patients with motor fluctuations compared with entacapone6

A new post-hoc analysis of the real-world OPTIPARK study showed that the majority of treatment-emergent adverse events (TEAEs) that were considered at least possibly related to opicapone occured within the first week of treatment, followed by consistently low incidence of TEAEs (<4%) from the third week onwards for 6 months. Within the first week of treatment, dyskinesia was the most frequently reported TEAE but had a very low impact on patient discontinuation (<0.5%). These observations are relevant for patient management concerning levodopa adjustment in clinical practice.1

Additionally, evaluation of three further datasets from the BIPARK–I and II trials7,8 demonstrated the potential for opicapone as a first-line adjunctive therapy to levodopa in PD patients with motor fluctuations:

1.   Opicapone demonstrated added benefit as a first adjunctive COMT inhibitor, in comparison with placebo and entacapone, in levodopa-treated PD patients recently diagnosed with motor fluctuations.2

2.   Another evaluation confirmed these findings and provides evidence for prompt use in the motor fluctuations spectrum of patients’ disease course.4

3.   Opicapone also showed increased effect in reducing OFF-time when used as a first add-on to levodopa or when used in combination with levodopa regimens containing other anti-PD medications.3

Finally, a review of home-diary data of 235 patients treated with 50 mg of opicapone or entacapone in the BIPARK-I7 trial showed that treatment with opicapone led to a greater increase in the proportion of patients who woke up in ON-status than treatment with entacapone (12.2% increase from baseline for opicapone compared with 7.5% for entacapone). Reduction in morning OFF-time was two-fold greater for opicapone versus entacapone (20%/h vs 10%/h).6

Professor Heinz Reichmann, Professor of Neurology at the University of Dresden, said:

Opicapone has demonstrated its potential in a real-life setting, offering a generally well-tolerated adjunct to levodopa for Parkinson’s patients with motor fluctuations, with low incidence of treatment-related adverse events over time. Alongside the efficacy data published earlier this year, this is valuable additional information for clinicians considering opicapone use in routine clinical practice.

Professor Soares da Silva, Director of Research & Development of Bial, shared his thoughts on the wealth of opicapone data being presented:

The amount of data we are presenting at MDS is indicative of our ongoing commitment to and investment in Parkinson’s Disease. Motor fluctuations can have a considerable impact on quality of life for people with Parkinson’s and our focus is on offering effective solutions with manageable tolerability. These new data demonstrate the potential for opicapone for use in a range of patients experiencing motor fluctuations, regardless of the point at which they occur.

 BIAL presented opicapone data from 16 abstracts at the MDS 2020 Virtual Congress.

Overview of key abstracts:

  • Onset of Drug-Related Adverse Events in Parkinson’s Disease Patients with Motor Fluctuations Treated with Opicapone in Clinical Practice: OPTIPARK Post-Hoc Analysis – POSTER, Abstract #10291
  • Efficacy and Safety/Tolerability of Opicapone in Catechol-O-Methyltransferase Inhibitor-Naïve Parkinson’s Disease Patients Recently Diagnosed with Motor Fluctuations – POSTER, Abstract #10282
  • Efficacy of Opicapone in Different Levodopa-Containing Treatment Regimens in Parkinson’s Disease Patients with Motor Fluctuations – POSTER, Abstract #9733
  • Opicapone’s Added Benefit as a First-Line Adjunctive Therapy to Levodopa and when Used Promptly in the Motor Fluctuations Spectrum of Parkinson’s Disease: A Post-Hoc Analysis of BIPARK-I and II – POSTER, Abstract #9944
  • Efficacy of opicapone compared to entacapone in catechol-O-methyltransferase inhibitor-naïve Parkinson’s disease patients recently diagnosed with motor fluctuations: a post-hoc conservative analysis – POSTER, Abstract #9985
  • Effect of Opicapone and Entacapone on Early Morning-OFF Pattern in Parkinson’s Disease Patients with Motor Fluctuations – POSTER, Abstract #10716

References

1. Lees A, et al. Onset of Drug-Related Adverse Events in Parkinson’s Disease Patients with Motor Fluctuations Treated with Opicapone in Clinical Practice: OPTIPARK Post-Hoc Analysis. MDS 2020 Abstract #1029.

2. Lees A, et al. Efficacy and safety/tolerability of opicapone in catechol-O-methyltransferase inhibitor-naïve Parkinson’s disease patients recently diagnosed with motor fluctuations. MDS 2020 Abstract #1028.

3. Antonini A, et al. Efficacy of opicapone in different levodopa-containing treatment regimens in Parkinson’s disease patients with motor fluctuations. MDS 2020 Abstract #973.

4. Ebersbach G, et al. Opicapone’s added benefit as a first-line adjunctive therapy to levodopa and when used promptly in the motor fluctuations spectrum of Parkinson’s disease: a post-hoc analysis of BIPARK-I and II. MDS 2020 Abstract #994.

5. Ferreira JJ, et al. Efficacy of opicapone compared to entacapone in catechol-O-methyltransferase inhibitor-naïve Parkinson’s disease patients recently diagnosed with motor fluctuations: a post-hoc conservative analysis. MDS 2020 Abstract #998.

6. Videnovic A, et al. Effect of opicapone and entacapone on early morning-OFF pattern in Parkinson’s disease patients with motor fluctuations. MDS 2020 Abstract #1071.

7. Ferreira JJ, et al. Opicapone as an adjunct to levodopa in patients with Parkinson’s disease and end-of-dose motor fluctuations: a randomised, double-blind, controlled trial. Lancet Neurol. 2016;15(2):154–65.

8. Lees A, et al. Opicapone as Adjunct to Levodopa Therapy in Patients With Parkinson Disease and Motor Fluctuations A Randomized Clinical Trial. JAMA Neurol. 2017;74(2):197–206

9. Ongentys® EU SmPC. Last updated 22/04/2020

10. Reichmann H, et al. Effectiveness and safety of opicapone in Parkinson’s disease patients with motor fluctuations: the OPTIPARK open-label study. Transl Neurodegener. 2020;9;1–9.

11. Kouli A, et al. Parkinson’s Disease: Pathogenesis and Clinical Aspects. 2018 Ch 1.

About ONGENTYS® (opicapone)[9]

Opicapone is a once-daily, peripherally-acting, third-generation, highly-selective COMT inhibitor.

Opicapone works by decreasing peripheral levodopa’s conversion rate into 3-O-methyldopa, thereby prolonging the duration of levodopa’s effect in reducing the OFF-time period of PD and extending the ON-time period.

In June 2016, the European Commission authorised ONGENTYS® (opicapone) as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors (DDCIs) in adult patients with PD and end-of-dose motor fluctuations who cannot be stabilised on those combinations. In Europe, opicapone is currently marketed in Germany, United Kingdom, Spain, Portugal, and Italy.

In April 2020, the U.S Food and Drug Administration (FDA) approved ONGENTYS® (opicapone) as an add-on treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes. BIAL entered into an exclusive licensing agreement with Neurocrine Biosciences in February 2017 for the development and commercialisation of opicapone in the U.S. and Canada. ONGENTYS® (opicapone) will be available in the U.S. in September, 2020.

In November 2019, ONGENTYS® (opicapone) was approved by the regulatory authorities of South Korea and will be commercialised by BIAL’s partner SK chemicals. ONGENTYS® (opicapone) is marketed in Japan by BIAL’s partner Ono Pharmaceutical Co., Ltd., after approval of the Japanese authority in June 2020. 

About the OPTIPARK Post-Hoc Analysis10

OPTIPARK was a Phase IV, open-label, single-arm prospective study conducted in the UK and Germany under clinical practice conditions.

This large real-life study in 495 patients treated with opicapone 50 mg mirrored a clinical setting through the inclusion of a broad population of fluctuating PD patients compared to the two-Phase III studies (BIPARK I and II).

Opicapone 50 mg was administered once daily for 3 months (German sites) or 6 months (UK sites) in addition to current treatment with levodopa/DDCI. Total daily levodopa/ DDCI dose could be adjusted according to the individual’s condition throughout the study (except on Day 1).

The primary endpoint was Clinician’s Global Impression of Change (CGI-C) after 3 months. The secondary endpoints were Patient Global Impressions of Change (PGI-C), the Unified PD Rating Scale (UPDRS), Parkinson’s Disease Questionnaire 8 items (PDQ-8), and the Non-Motor Symptoms Assessment Scale (NMSS).

About the BIPARK-I study7

BIPARK–I was a Phase III, randomised, double-blind, active- and placebo-controlled, parallel group efficacy and safety study with an open-label, 1-year extension Phase in levodopa-treated patients with idiopathic PD and motor fluctuations.

The efficacy and safety of three different doses (5, 25 and 50 mg) of opicapone administered once daily, compared with entacapone (200 mg) or placebo administered with each dose of levodopa, were assessed. Opicapone 50 mg once-daily was superior to placebo and non-inferior to entacapone.

The study enrolled 600 patients from 106 study sites in Europe. Patients were 34–83 years old and had a diagnosis of idiopathic PD for at least 3 years; had a modified Hoehn & Yahr Scale stage of ≤3 in the ON state; had to receive optimum levodopa therapy (3–8 daily doses), stable for at least 4 weeks; had signs of end-of-dose deterioration (wearing-OFF) for at least 4 weeks with a mean daily OFF-time of at least 1.5 hours while awake, not including morning pre-first dose OFF-time; and had the ability to keep accurate 24-hour diaries. Patients were randomly assigned in a 1:1:1:1:1 ratio to opicapone 5 mg, 25 mg or 50 mg, entacapone and placebo.

The primary endpoint was the mean change from baseline in absolute OFF-time, as measured by 24-hour diaries. Secondary endpoints included proportion of responders, Investigators’ and Subjects’ Global Assessment of Change, UPDRS, quality of life, non-motor symptoms and sleep scales, tolerability, and safety assessments. Ninety percent (542/600) of patients completed the study.

About the BIPARK-II study8

BIPARK-II was a Phase III, randomised, double-blind, placebo-controlled study with an open-label 1-year extension phase in levodopa-treated patients with idiopathic PD and end-of-dose motor fluctuations.

The efficacy and safety of two different doses (25 and 50 mg) of opicapone, administered once daily compared with placebo, were assessed. Mean reduction in absolute OFF-time in both the 25 and 50 mg opicapone groups was greater than in the placebo arm.

286 patients completed the study from multinational study sites. Patient inclusion criteria and trial assessments (primary and secondary outcomes) were similar to BIPARK-I.

For more information on BIAL: www.bial.com

Funding boost for AI-based epilepsy monitoring

Posted on September 22, 2020 by - Epilepsy

University spinout company Neuronostics has received funding to develop its BioEP platform, an AI-based system for faster, more accurate diagnosis of epilepsy and to monitor response to treatment with anti-epileptic drugs (AEDs). 

BioEP works by creating mathematical models of the brain using short segments of electroencephalogram (EEG) recordings. Computer simulations rapidly reveal the ease with which seizures can emerge and form the basis of the BioEP seizure risk score.

Neuronostics is developing BioEP in partnership with the University of Birmingham, where mathematician Professor John Terry, co-founder of the company, is Director of Centre for Systems Modelling & Quantitative Biomedicine. 

Professor Terry’s research aims to improve diagnosis and treatment for people with epilepsy.  He explains: 

We build personalised models of the brain using EEG that is routinely collected when seeking to diagnose epilepsy. From these models the risk of epilepsy can be quickly determined. In contrast, multiple EEG recordings are often required to reach a clinical diagnosis at present. This is expensive, time-consuming, and exposes people with suspected epilepsy to risk. 

The funding, from the National Institute for Health Research (NIHR), will enable the research partnership to progress a prototype clinical platform that can provide a risk score showing the individual’s susceptibility to seizures.  This measurement can be used in diagnosis, and as an objective assessment of response to treatment with AEDs, resulting in faster seizure control for people with epilepsy. 

The clinical utility of the BioEP seizure risk score has already been demonstrated in a cohort of people with idiopathic generalized epilepsy.1  Using just 20 seconds of an EEG recording that would be considered inconclusive in the current clinical pathway, BioEP achieved 72% diagnostic accuracy.  This matches the accuracy achieved in the current diagnostic pathway, which typically takes a year, and involves multiple follow-ups.2

The company is interested to hear from commercial partners in EEG hardware manufacturing, digital EEG analysis, and companion diagnostics or prognostics, and research and clinical partners with interests in epilepsy, traumatic brain injury and dementia.

The NIHR funding was delivered through the AI in Health and Care Award, part of the NHS AI Lab, which was launched by the UK Government earlier in 2020 to accelerate the adoption of Artificial Intelligence in health and care. 

References

  1. H Schmidt et al. A computational biomarker of idiopathic generalized epilepsy from resting state EEG Epilepsia 57: e200-e204 (2016).
  2. S Smith. EEG in the diagnosis, classification, and management of patients with epilepsy Journal of Neurology, Neurosurgery & Psychiatry 76: ii2-ii7 (2005).

About Neuronostics

Neuronostics was established in 2018 and is focused on developing clinical decision support tools and at home monitoring devices for people with suspected neurological conditions. Neuronostics is currently Medilink SW Start up of the Year and has been supported by grant funding in excess of £1M. Neuronostics’ first product – BioEP – is a revolutionary, patented, biomarker of the susceptibility to seizures in the human brain, informed by clinical EEG recordings.

About the University of Birmingham

The University of Birmingham is ranked amongst the world’s top 100 institutions. Its work brings people from across the world to Birmingham, including researchers, teachers and more than 6,500 international students from over 150 countries.

About NIHR

The National Institute for Health Research (NIHR) is the nation’s largest funder of health and care research. The NIHR:

  • Funds, supports and delivers high quality research that benefits the NHS, public health and social care
  • Engages and involves patients, carers and the public in order to improve the reach, quality and impact of research
  • Attracts, trains and supports the best researchers to tackle the complex health and care challenges of the future
  • Invests in world-class infrastructure and a skilled delivery workforce to translate discoveries into improved treatments and services
  • Partners with other public funders, charities and industry to maximise the value of research to patients and the economy

The NIHR was established in 2006 to improve the health and wealth of the nation through research, and is funded by the Department of Health and Social Care. In addition to its national role, the NIHR supports applied health research for the direct and primary benefit of people in low- and middle-income countries, using UK aid from the UK government.

SPRAVATO®▼ (esketamine) nasal spray for treatment-resistant major depressive disorder recommended in Scotland – but not England

Posted on September 3, 2020 by - Major Depressive Disorder

The Janssen Pharmaceutical Companies of Johnson & Johnson are delighted that the Scottish Medicines Consortium (SMC) accepted SPRAVATO®▼ (esketamine) nasal spray (7th September 2020) for use within NHS Scotland in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI), for adults with treatment-resistant Major Depressive Disorder (TRD), who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode. SPRAVATO®▼ (esketamine) nasal spray offers a new mechanism of action to treat MDD, in a therapy area that has had little innovation since the introduction of SSRIs or SNRIs over 30 years ago.

Major depressive disorder (MDD) is a significant health condition that has a profound impact on people’s lives. Up to 30 per cent of people living with MDD are considered to have TRD, which can cause significantly lower health-related quality of life, reduced productivity at work and increased absenteeism. Read more here.

The SMC advice is based on data from the robust Phase 3 clinical trial, including the TRANSFORM-2 trial which showed that in adults (aged 18 to 64 years) with treatment resistant depression, esketamine nasal spray plus newly initiated oral antidepressant significantly reduced (p=0.02) the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 4 compared with placebo nasal spray plus newly initiated oral antidepressant.

However, the company is disappointed with the National Institute for Health and Care Excellence (NICE) second draft guidance published on 3rd September, that does not recommend SPRAVATO®▼ (esketamine) nasal spray in England.[i]

“It is a real shame that this treatment will now need to go through a third appraisal committee and is extremely frustrating for clinicians and for patients living with treatment-resistant major depressive disorder who are in desperate need of an alternative treatment option,” commented Amanda Cunnington, Director of Health Economics, Market Access & Reimbursement (HEMAR) and Advocacy, Janssen-Cilag Limited. “It is important that Janssen and NICE work together along with other stakeholders to make sure that innovative treatments in mental health, such as esketamine nasal spray, are able to navigate the NICE appraisal process and, once approved, be used in clinical practice.

There are real challenges in the way mental healthcare is considered that limits access and uptake of innovation, which contributes to the disparity between treatments for physical and mental health.”

NICE has recognised the negative impact treatment-resistant depression has on patients, their families and carers, and the unmet need for new effective treatment options. Depression is the leading cause of disability worldwide and is one of the conditions most frequently associated with suicide.[ii],[iii] Major depressive disorder is a serious disease that causes a significant, negative impact on the way people think, feel and act.[iv] Symptoms and severity vary by person and may include: persistent feelings of sadness; hopelessness or tension; changes in sleep or appetite; difficulty concentrating or performing activities of daily living; lack of interest; and/or thoughts of harming themselves.[iv],[v]

Janssen believes that, based on the evidence submitted, esketamine nasal spray is a cost-effective use of National Health Service (NHS) resources. Janssen is seeking to address NICE’s concerns and is confident that based on further technical responses and additional discussions with NICE, a route can be found for esketamine nasal spray to be made available for eligible patients in England.

The consultation on the second draft guidance is open until 25 September 2020. Final guidance is expected later this year.

Further reading

Major Depressive Disorder – where are we falling short? 
Professor Ramin Nilforooshan, Consultant Psychiatrist, Surrey and Borders Partnership NHS Foundation Trust, University of Surrey

References

[i] NICE. Appraisal consultation document. Esketamine for treating treatment-resistant depression. Available at: https://www.nice.org.uk/guidance/indevelopment/gid-ta10371/documents. Accessed September 2020.

[ii] World Health Organization. Depression Factsheet. Available at: www.who.int/news-room/fact-sheets/detail/depression. Accessed September 2020.

[iii] Brådvik L. Suicide Risk and Mental Disorders. Int J Environ Res Public Health. 2018;15(9):2028. doi:10.3390/ijerph15092028

[iv] American Psychiatric Association. Diagnostic and statistical manual of mental disorders (5th ed.). 2013 Arlington, VA: American Psychiatric Publishing.

[v] National Institute for Health and Care Excellence. Depression in adults: treatment and management. Full guideline (Consultation draft May 2018). Available at www.nice.org.uk/guidance/gid-cgwave0725/documents/full-guideline-updated. Accessed September 2020

[vi] Popova V, et al. Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study. Am J Psychiatry 2019;176(6):428-43.

[vii]Ochs-Ross R, et al. Efficacy and safety of esketamine nasal spray plus an oral antidepressant in elderly patients with treatment-resistant depression. The American Journal of Geriatric Psychiatry 2019;28(2):121-141.

[viii] Fedgchin M, et al. Efficacy and Safety of Fixed-Dose Esketamine Nasal Spray Combined With a New Oral Antidepressant in Treatment-Resistant Depression: Results of a Randomized, Double-Blind, Active-Controlled Study (TRANSFORM-1). Int J neuropsychopharmacol 2019;22(10):616-630.

[ix] Daly E et al. Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2019;76(9):893-903.

[x] Wajs E, et al. Long-Term Safety of Esketamine Nasal Spray Plus Oral Antidepressant in Patients with Treatment-Resistant Depression: Phase 3, Open-Label, Safety and Efficacy Study (SUSTAIN-2). J Clin Psychiatry 2020; 81(3):19m12891.

[xi] Daly E, et al. Efficacy and safety of intranasal esketamine adjunctive to oral antidepressant therapy in treatment-resistant depression. JAMA Psychiatry 2018;75(2):139-148.

Teva launches pre-filled pen for anti-CGRP migraine therapy AJOVY®▼ (fremanezumab) in the UK

Posted on August 8, 2020 by - Headache

On 21st July 2020, Teva UK Limited announced that a pre-filled pen for AJOVY® (fremanezumab) injection is now available, which will give patients on AJOVY® added convenience and flexibility not previously available with the AJOVY® pre-filled syringe. Indicated for the prevention of migraine in adults who have at least 4 migraine days per month, AJOVY® offers quarterly and monthly dosing options. It is the first and only anti-CGRP drug recommended for use on the NHS in England and Wales by the National Institute for Health and Care Excellence (NICE) for chronic migraine patients. Within NHS Scotland, it is accepted for restricted use by the Scottish Medicine Consortium (SMC) for chronic and episodic migraine.1 AJOVY® is an option for migraine patients who have not responded to at least three prior preventive treatments.1

“Chronic migraine is a debilitating neurological disorder which can, without the right treatment, strike at any time leaving the sufferer feeling helpless,” comments Dr Mark Weatherall, Chair of the British Association for the Study of Headache. “Fremanezumab is well tolerated, effective and particularly useful for complex migraine patients, where other treatments have failed. Patients are often worried about using traditional syringes to inject themselves. A pen device is simple to self-administer and increases patients’ control over their own management of their condition.”

“As healthcare professionals, we want to be able to get patients onto migraine specific treatments expediently. However, headache/migraine specialist clinics are often challenged by high caseloads,” adds Neurology Nurse Prescriber Rebecca Stuckey, University Hospitals Plymouth NHS Trust, “A pen device which patients can easily self-administer will reduce appointments and waiting times. This option will also be welcomed by my patients, who can travel 2-3 hours to the clinic for appointments.”

Previously migraine prevention therapies were limited to treatments repurposed from other disease areas (such as beta-blockers, anti-epileptics, anti-depressants and botulinum toxin injections).2 Botulinum toxin, requiring a minimum of 31 injections into the head or neck per treatment, has to be administered by a healthcare professional at a specialist centre.3 AJOVY® belongs to a class of treatments called anti-CGRP (calcitonin gene-related peptide) monoclonal antibodies, which have been specifically designed to target the underlying causes of migraine. AJOVY® is the only long-acting anti-CGRP injection with the option of dosing four times or twelve times per year using either a pre-filled syringe or the new pre-filled pen. The new AJOVY® pre-filled pen has several features that make it easy-to-use including a button-free, push-down mechanism, audible cues that signal progress of administration, and a window that displays when the dose has been delivered.4 Additionally, the pre-filled pen is for one-time use only and locks after use. AJOVY® can be injected into areas of the abdomen, thigh, or upper arm that are not tender, bruised, red or indurated. Injection sites should be alternated/ rotated.5 It was developed in the UK at Teva’s research and development site in Abbots Park, Runcorn, Cheshire.

“At our Combination Product and Device R&D site in Runcorn we developed the AJOVY® pre-filled pen out of a deep desire to improve the lives of chronic migraine sufferers,” said Paul Bridges, Senior Director CPD R&D at Teva UK’s Abbots Park, R&D site in Runcorn, Cheshire. “We’re really proud that the pre-filled pen was designed and developed here in the UK, and will offer more user friendly treatment options for patients with migraine.”

“We’re delighted to now be able to offer the option of a pre-filled pen device for AJOVY® patients in the UK,” said Kim Innes, General Manager of Teva UK and Ireland. “Earlier this year AJOVY® was the first anti-CGRP medicine recommended by NICE, and we’re pleased to be able to offer people struggling with migraine even greater flexibility and control over their treatment.” Patients may self-inject at home once instructed in subcutaneous self-injection technique by a healthcare professional. This has the potential to free up NHS resources such as nurse or consultant time.

Patients can use the Rain Free Days application for guidance about using AJOVY®, and instructional videos are available from products.tevauk.com. Teva is also providing a fully funded Homecare service which includes training by a nurse.

Read more ACNR migraine articles.

About AJOVY® (fremanezumab)

AJOVY® (fremanezumab) is indicated for the prophylaxis of migraine in adults who have at least four migraine days per month. AJOVY® is available as a 225mg/1.5mL single dose injection in a pre-filled syringe or pre-filled pen with two dosing options – 225mg monthly administered as one subcutaneous injection, or 675mg every three months (quarterly), administered as three subcutaneous injections. Like all injections, there is a chance of a skin reaction around the injection site e.g. redness, hardness or itching. AJOVY® can be administered at home by a patient or caregiver, if instructed by a healthcare professional. Full product information can be accessed from the Teva website: http://products.tevauk.com/p/ fremanezumab-728?productId=19035 • The Scottish Medicines Consortium (SMC) accepted AJOVY® for restricted use within NHS Scotland (January 2020), for the treatment of patients with chronic and episodic migraine who have had prior failure on three or more migraine preventive treatments. The guidance can be viewed online on the SMC website: https://www.scottishmedicines.org.uk/medicines-advice/fremanezumab-ajovy-fullsmc2226/ • National Institute for Health and Care Excellence (NICE) recommended AJOVY® (fremanezumab) for use within NHS England and Wales (June 2020) for the prophylaxis of migraine in adults with chronic migraine who have not responded to at least three prior preventive treatments. The technology appraisal guidance can be viewed online on the NICE website: https://www.nice.org.uk/guidance/ta631

References

1. The Migraine Trust – www.migrainetrust.org/living-with-migraine/treatments/calcitonin-gene-related-peptide-pathway-monoclonalantibodies/. Last accessed: July 2020

2. Khan S. et al. ‘CGRP, a target for preventive therapy in migraine and cluster headache: Systematic review of clinical data’. Cephalalgia (2019); 39(3): 374-389

3. Botox® SmPC. Allergan Ltd. 2019. Available at www.medicines.org.uk/emc/product/859/smpc

4. Two Human Factor studies assessed evaluators’ ability to complete critical tasks in order to demonstrate use of the AJOVY Autoinjector in simulated-use sessions. When asked “Was the autoinjector easy to use?”, 97% in study 1 (N=30) and 98% in study 2 (N=47) answered “Yes.” Data on file, Parsippany, NJ Teva Pharmaceuticals USA, Inc.

5. AJOVY® SmPC. Teva UK Ltd. 2019. Available at https://www.medicines. org.uk/emc/product/10386/smpc. Last accessed: July 20206. Pavone E. et al. ‘Patterns of triptans use: a study based on the records of a community pharmaceutical department’. Cephalalgia (2007); 27: 1000-1004.

7. NHS – Migraine (www.nhs.uk/conditions/ migraine/symptoms/) Last accessed: July 2020

8. Migraine Trust – Facts and Figures https://www.migrainetrust.org/about-migraine/migraine-what-is-it/facts-figures/ (figure based on current UK adult population from the Office of National Statistics – www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/articles/overviewoftheukpopulation/february2016) Last accessed: July 2020

9. Buse DC. et al. ‘Chronic Migraine Prevalence, Disability, and Sociodemographic Factors: Results From the American Migraine Prevalence and Prevention Study’. J Head Face Pain; 52: 1456-1470. doi:10.1111/j.1526- 4610.2012.02223.x

10. Chronic migraine population calculated by using 12% of migraine population (1 in 7 total population) as cited by Buse (above) amongst context of current UK population statistics from Office of National Statistics. Population estimates for the UK, England and Wales, Scotland and Northern Ireland: mid-2018. https:// www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/ populationestimates/bulletins/annualmidyearpopulati onestimates/mid2018 Last accessed: July 2020

AJO-UK-NP-00007 Date of Preparation: July 2020

UKABIF Film Award Winner

Posted on July 30, 2020 by - Acquired Brain Injury

Sacha Paynter from Bristol has won the United Kingdom Acquired Brain Injury Forum (UKABIF) Film Award for her film ‘Talking Benefits’, sponsored by Cygnet Health Care. 

Sacha’s short film looks at the importance of neurorehabilitation for individuals who have had an Acquired Brain Injury (ABI).  The film is based on Sacha’s personal family experiences of ABI, and being a carer for both parents who had a brain injury at different times in her life.  Sacha’s father had a brain aneurysm when she was a teenager, which sadly resulted in his death, and her mother had a stroke a few years ago. 

Commenting on film Sacha said: “My mum received neurorehabilitation in hospital and it was really successful.  It’s essential that people have early access to neurorehabilitation following a brain injury like a stroke or an aneurysm, and I’ve seen the wonders that neurorehabilitation can do for an ABI patient in hospital.  Neurorehabilitation can result in a speedy, efficient recovery with long-term benefits and a better quality of life”.  

The judges commented: ‘We really liked the creative way Sacha made her points. She used her experiences to explain really simply how neurorehabilitation works and what the benefits are to the patient and family. ”

Chris Bryant, MP for the Rhondda Valley and Chair of the All-Party Parliamentary Group for Acquired Brain Injury announced Sacha as the winner of the award on Monday 13th July.  He said: “We are really struck by the fact that nearly every department of government needs to take into account the numbers of people they represent who are affected by brain injury.  We need people, like Sacha, to share their stories to get our message across.”

Rachael Chamberlain, Business Development Director at Cygnet Health Care said: “Cygnet is delighted to be sponsoring the UKABIF Film Award.  Neurorehabilitation has a key role in the patient care pathway following an ABI. We will use the film as part of our induction training programme for new staff as it explains the importance of neurorehabilitation so clearly and simply.”

Sacha’s film can be viewed here (https://m.youtube.com/watch?v=9oUXPj49SWo&feature=youtu.be)

You can also see UKABIF’s Chair, Dr Andrew Bateman, Cygnet’s Rachael Chamberlain and Chris Bryant presenting Sacha with the UKABIF film award here (https://www.youtube.com/watch?v=WTTTAkIZS58)

The film will be shared widely across social media to help explain simply what neurorehabilitation involves and why it works.

Online auction for Newly Injured Scheme

Posted on July 23, 2020 by - Charity, Rehabilitation

Neurokinex, a specialist paralysis rehabilitation charity with sites at Gatwick, Hemel and Bristol, is running an online auction for two weeks from noon on Friday July 17th until noon on Friday July 31st to raise funds to safeguard the future of its Newly Injured Scheme.

The auction includes a wide choice of lots including sports and popular culture memorabilia, iconic art, UK experiences and short breaks at home and abroad.

Particular highlights include:

  • A Beatles display signed by all four members of the band
  • Jonny Wilkinson signed England rugby shirt
  • Limited edition David Bowie portrait
  • Raymond Blanc cookery lesson for two
  • Anthony Joshua signed boxing glove
  • Ascot and Lord’s Pavilion experiences
  • Rafael Nadal signed tennis racquet
  • Andy Warhol’s famous Marilyn Monroe portrait

Other lots including a champagne tea in London, a hand-drawn pet portrait, Lake District break, a castle stay in Bordeaux and a Gin Club membership ensure there really is something for all tastes and budgets. 

The auction is the finale of the two-month Neurokinex Step Up Appeal – an emergency fundraising effort with a target of £25,000 – to secure vital services for people with a newly acquired spinal cord injury.  Prior to the Covid-19 lockdown, Neurokinex operated a Newly Injured Scheme which awards six free sessions to those newly injured or diagnosed and referred by the NHS. The service is a lifeline for many, giving them access to the unique Neurokinex services that can have life-changing results.  It costs Neurokinex £420 per person but, sadly, following lost income over the lockdown, without additional fundraising it is now under serious threat of being withdrawn.

“It’s great to have facilities that spinal cord injured individuals can access after their inpatient hospital admission has come to an end. The six free sessions on offer at Neurokinex for new injuries is a hugely important resource that helps to bridge the gap between discharge and access to community professionals facilitating community reintegration. The feedback received from returning patients, having been treated by Neurokinex, is that the team is fun and dynamic. They all see Neurokinex as a very important part of their long-term rehabilitation and fitness regime, so it’s vital we continue to ensure we can keep services like theirs running.”

Kirsten Hart, Clinical Specialist Physiotherapist at Stoke Mandeville Hospital

“Now, more than ever before, we need support from the public and hope that our Step Up Appeal will raise the necessary funds to keep our referral service going,” says Harvey Sihota, founder and director of Neurokinex.  “We have a waiting list of hopeful beneficiaries who are waiting for their rehabilitation with us to begin.  Our hope is that this silent auction will boost our Step Up Appeal funds to enable people to start on our programme without delay.”

The two-week long Silent Auction goes live at 12 noon on Friday July 17th  https://givergy.uk/neurokinex/.

To make a donation visit: https://www.paypal.com/uk/fundraiser/charity/2391620

To find out more see https://neurokinex.org/step-up-appeal/neurokinex

Hereditary Spastic Paraplegia (HSP) Support Group

Posted on June 29, 2020 by - Charity, Hereditary Spastic Paraplegia

The Hereditary Spastic Paraplegia (HSP) Support Group is a small UK charity run by volunteers. It aims to provide support to those with HSP, their families and their carers. The group creates a friendly community allowing its members to feel less isolated and share their stories with each other.

The charity regularly runs local meetings across the country, with a larger AGM in July. They publish a newsletter 2-3 times a year and keep their website up to date (https://hspgroup.org/). They also have a private Facebook page, which can be accessed (https://www.facebook.com/hspgroup.org/), where members can discuss anything they want.         

Members can apply for funding for mobility aids or other equipment to improve their quality of life. Members fundraise and the charity are proud of their annual Potato Pants Festival (http://potatopantsfestival.co.uk/). They also provide research grants to promote HSP research, part funding two UK PhDs this year.

The charity are striving to make themselves better known to relevant healthcare professionals, so that patients with HSP can be directed to them for support. They are there for the whole journey, not just the diagnosis, and would appreciate if healthcare professionals can:

  1. Advertise the group to patients/carers with HSP under your care and your colleagues
  2. Become honorary members of the group
  3. Help to identify guest speakers for their meetings
  4. Apply for small research grants which can be provided annually

Please contact:  mitesh.patel16@nhs.net or chair@hspgroup.org if you would like more information or leaflets.

Nearly a third of scientists could leave neuroscience research due to COVID-19

Posted on June 29, 2020 by - COVID-19 Articles

On 18th June, the British Neuroscience Association (BNA) released its survey results into the future of neuroscience after COVID-19, raising serious concerns over the future of vital research into the nervous system and its disorders.

Over 400 neuroscience researchers UK-wide responded to the survey, representing a variety of neuroscience research settings and career stages. The findings show a significantly high number of researchers have been affected by the impact of COVID-19, with nearly a third of researchers considering leaving neuroscience as a result.

Download report and full survey results here

Key findings:

  • 32% are considering leaving neuroscience research as a result of COVID-19, with over a quarter (27%) considering leaving research altogether
  • Around 88% have seen a negative impact on the overall progress of their research, with 46% viewing this as strongly negative.
  • Over a quarter (28%) have requested further support from their funder/s. Of these, around 47% are still awaiting a response.
  • Around 80% are concerned their research will be hindered by insufficient funding.
  • Over 85% believe that COVID-19 will have a negative impact on the neuroscience research sector as a whole.

In an urgent response to the findings, the BNA has already written a letter (click to download) to the Minister for Science, Research and Innovation, Amanda Solloway MP. In the near future, we will continue to engage with and work with funders, following on from our request for support at the start of lockdown.  

Commenting on the survey results, BNA President, Annette Dolphin, said: “It’s vital we understand the effect that the COVID-19 pandemic is having on current neuroscience research and on the future of the field. The range of concerns and issues highlighted by this survey shows the uncertainty facing neuroscientists, and the potentially devastating impact on this essential research into the nervous system and its disorders.

“Early in lockdown, the BNA wrote to research funders requesting they provide further support in order to keep neuroscience research on track. Going forward, the results of our survey provide important insight into how we can best represent the voice of the neuroscience community with universities, funders, employers and government, and provide the support researchers need, now and in the future.”

What some of our respondents are saying. . .

I might be forced out of science. My fellowship was for 20 months, I was 5 months in when the labs were closed – I’m not sure I’m going to get enough data for papers and follow on funding.” Early Career Research in molecular biology:

The uncertainty about when we can return to testing human participants will almost certainly have some seriously negative consequences for me and my research, but I am more concerned about how it is going to affect my junior colleagues: to our knowledge our PhD students’ studentships are not going to be extended to compensate for time lost unable to collect data. This is a very significant weight to expect our junior colleagues to shoulder.” Lecturer in human experimental medicine

[I’m considering] changing research type from face-to-face/neuroimaging to more distanced and qualitative work” Postgraduate researcher in human behaviour

I think a lack of funding opportunities could make it very difficult for early career researchers to progress in academia. There will be less opportunities and if they are competing against labs which are already established it will be very difficult to win grants. The knock-on effect is that they stay in postdoc positions (which there will be less available of) and they may out-compete newer postdocs based on experience or they leave research. The government must increase funding to help mitigate the impact of COVID-19. If the pandemic has done nothing, it has highlighted how crucial scientists are and they must be supported during this difficult time.” Early Career Researcher in animal behaviour

Aphasia: guide to digital communication tools

Posted on June 29, 2020 by - Industry News

The Stroke Association launched the ‘Getting Online for People with Aphasia’ guide on June 16th, to mark Aphasia Awareness Month. The guide will:

  • Equip stroke survivors’ who have aphasia with the skills they need to get online and use tools, such as Skype, WhatsApp, Facebook and Zoom, so they can keep in touch with family and friends
  • Enable stroke survivors to connect with the stroke survivor community

This new digital guide has been designed following a UK-wide consultation of stroke survivors’ with aphasia2. It contains helpful information and step-by-step guidance on how to get online and search the internet. The guide uses aphasia-friendly text supported by pictures and key words. It can be used with a text reader and covers the use of many devices; computer, laptop, tablet and smart phone. It is the first element in a suite of digital resources for people affected by aphasia which the Stroke Association are producing.

As many as 350,000 stroke survivors with aphasia, a common communication disability, are at greater risk of becoming lonelier and more isolated during the pandemic, according to the Stroke Association1. While people across the UK have been able to keep in touch with their loved ones thanks to technology, the charity is now highlighting the struggle that stroke survivors’ with aphasia face getting online.  

Aphasia is a language and communication disorder, of which stroke is the most common cause. There are 1.2 million stroke survivors’ in the UK and around a third (33%) have aphasia1. Aphasia can affect a person’s ability to speak, read, write – and sometimes understand speech and use numbers. Aphasia affects language not intellect.

Pat Sweetingham (57) from Basingstoke, Hampshire had a stroke in June 2003 which left her with aphasia and epilepsy.

Pat said: “Aphasia can feel like an invisible disability. I can talk but I couldn’t write and reading is hard. Aphasia has been hard. At first I could not talk at all. I just had a few words. When you say you have aphasia most people do not know what you are talking about. Simple tasks like getting the bus, following directions or ordering coffee were challenging but have improved over time. Some days are better than others. Some days I am tired and it makes it worse.

“Technology will not be for everyone and some people will need extra support to use it. People with aphasia must be allowed to try things out for themselves and see what works for them. One person might find a tablet easy to use while another person would prefer a laptop. Lockdown has been especially hard for people with aphasia.

“My stroke group has been using online video calls to keep in touch but this does not work for everyone. We have a few members who are on their own and they do not know how to even use a computer. They have no one to talk to and have been cut off from their normal support. We have 6 group members who are now using video call. It makes a difference to all of the group members to connect with others who understand what they are going through. Our members enjoy coming to the group because they feel normal. 

“People with aphasia have smaller social circles and lockdown has taken away many of their support lifelines like the gym, grandkids or their stroke groups. They have no one to talk to and have been cut off from their normal support.”

Juliet Bouverie, Chief Executive of the Stroke Association said: “When stroke strikes part of your brain shuts down and so does part of you. A third of stroke survivors have aphasia, which can rob you of your ability to read, write or speak. This pandemic has created an epidemic of loneliness, particularly among stroke survivors with aphasia. Everyone’s world has shrunk due to the pandemic but imagine the agony of being confined to the walls of your own head.”

According to the Revealing Reality report (2019)3 commissioned by the charity, stroke survivors with aphasia said their disability was misunderstood by those close to them, as well as by the wider community. They also reported that isolation had negatively impacted their mental health and well-being, leaving them frustrated and low in confidence. The charity fears that aphasia may lead people to withdraw further from friends and family, putting them at even greater risk from isolation during the pandemic.

Juliet continues: “You don’t have to feel imprisoned by aphasia. This guide provides a vital lifeline and gives you the skills and confidence to get online. It’s particularly helpful for keeping in touch with loved ones, guiding you through things like video calling. Aphasia doesn’t go away and that’s why we’ve developed a tool to help overcome the challenges that you might face.

You don’t have to feel imprisoned by aphasia.

Juliet Bouverie, Chief Executive of the Stroke Association

“It opens up a world of opportunities that may not have been previously accessible to stroke survivors with aphasia. I’m urging you to use and share this guide. If you’re a stroke survivor with aphasia who needs help getting the guide or would like a printed version, please contact the Stroke Helpline (0303 3033 100). Stroke is a lonely experience, but we’re here to support you to rebuild your life after stroke. The guide will also help you to access My Stroke Guide an online community of stroke survivors where you can share experiences, ask questions and find solutions.”

Kamini Gadhok MBE, Chief Executive of the Royal College of Speech and Language Therapists said: “We know that a third of stroke survivors have aphasia and problems communicating and understanding how to use those little things that we take for granted, such as online technology to keep in touch with others. Even being able to read a phone number can be a huge struggle. These barriers often leave individuals feeling isolated and alone, so this new tool will help them to stay in touch with loved ones, keep connected with friends and find support from the aphasia community.” 

References

1. Stroke Association (2018) State of the Nation. (February 2018) Available at https://www.stroke.org.uk/sites/default/files/state_of_the_nation_2018.pdf

2. Aphasia Suite (2018): Consultation with People with Aphasia. Report for the Stroke Association on the Consultation with People who have Aphasia.*

3. Revealing Reality (2019). Life with aphasia – Stage 2 report.*

*These reports are not yet publicly available. If you would like further information please contact: Sokina Miah PR & Media Officer at the Stroke Association at Sokina.miah@stroke.org.uk