“Congratulations to the WFNR for all that it has achieved over the last 25 years. Today the WFNR is a true advocate for neurorehabilitation” said Professor David Good, WFNR President as the organisation celebrates its 25th anniversary. He continued: “We’re extremely grateful to all our members who have contributed to the success of the organisation in so many ways”.
The WFNR is a vibrant and dynamic multidisciplinary organisation, advancing the development and improving neurorehabilitation services across the world. In addition to over 5000 members and 37 Special Interest Groups, the WFNR is now affiliated to 41 National Societies in various countries. It hosts a biennial World Congress for Neurorehabilitation that rotates around the continents with the next WCNR heading to Vienna, Austria from the 14-17 December 2022.
Reflecting on the last 25 years Professor Michael Barnes, the founder of the WFNR said: “Our original aim has been met – to create a global organisation bringing together health professionals with an interest in neurorehabilitation. It is now a recognised and respected sub speciality of neurology. We now serve our patients much better than we used to and I think the WFNR has played a major role in that change. Thank you everyone!”
“Neurorehabilitation has an exciting future. The WFNR will continue to play a major role as a ‘translational hub’, educating members about new science and technology. There are so many new advances on the horizon; the use of brain computer interfaces, virtual and augmented reality, artificial intelligence, and better biomarkers to name just a few. The future looks bright for our patients.”
Professor Volker Hoemberg, President-Elect
In celebration the WFNR has just launched its new website www.wfnr.co.uk and new members are always welcome.
Stroke is one of the most common causes of disability across the world. Up to 80% of acute stroke patients experience loss of arm function, which affects quality of life. Arm impairment often persists after rehabilitation has ceased. Recovery may be optimised by intensive functional training, but this can be difficult after stroke e.g. due to fatigue, pain, or depression. Commercial games may improve arm function after stroke (Thomson et al, 2014), by increasing engagement with activities at home, providing a low-cost adjunct to rehabilitation with off the shelf technology. However, most commercial games have not been designed for people with disabilities and require adaptation. Additionally, music psychology research demonstrates the benefits of preferred music listening on mood and of rhythmic auditory stimulation on arm function in stroke survivors. At GCU, we have developed a bespoke prototype music game, which integrates rhythmic auditory stimulation with repetitive practice, based on individuals’ preferred music. This game, which uses off-the-shelf technology, has been specifically designed for stroke survivors with a range of impairments (Averell & Knox, 2019).
Aims & Objectives
To further develop this prototype to optimise its therapeutic potential and usability by considering design requirements from stroke survivors/carers, and health professionals such as occupational therapists/ physiotherapists. Based on the applicant objectives may comprise:
To conduct a systematic review of music-based gaming for stroke arm rehabilitation.
To further develop, with engineers in audio-technology, a prototype music-based game, through involvement of stroke survivors/carers, and health professionals.
To conduct a feasibility study, exploring the feasibility, acceptability and preliminary effects of using the prototype.
Specifications
The successful applicant will be an Occupational Therapist or Physiotherapist holding the minimum of a first degree (2:1 or above). An interest in games for health, and previous experience of mixed methods or qualitative research is desirable. This project is available as a 3 years full-time or 6 years part-time PhD study programme with expected start date of 1 October 2021
Analysis of consistency in migraine days over the course of a dosing regimen for AJOVY® (fremanezumab-vfrm) Injection published in Headache – Analysis assessed migraine days at the beginning and end of quarterly and monthly dosing intervals
Results from a post hoc analysis of a long-term, open-label extension study assessing migraine days at the beginning and end of quarterly and monthly dosing intervals of AJOVY® (fremanezumab-vfrm) injection were published in the October 2020 issue of Headache: The Journal of Head and Face Pain.
“We are proud to share this analysis and demonstrate our continued commitment to advancing the understanding of treatment options for patients living with migraine,” said Denisa Hurtukova, MD, Vice President, Head of North America Medical Affairs, Teva. “This analysis helps us better understand patients’ experience with AJOVY, as well as the impact of quarterly and monthly dosing options.”
The post hoc analysis compared migraine days in the initial and final weeks of quarterly or monthly dosing regimens of AJOVY during up to 15 months of treatment. The analysis included 1,043 patients with chronic migraine (CM) (n=611) and episodic migraine (EM) (n=432) who were initially enrolled in the pivotal placebo controlled HALO CM and EM studies and then continued in the long-term, 12-month, multicenter, randomised, parallel group Phase 3 study with double blind dosing regimens. Patients received AJOVY either quarterly or monthly.
Utilising patients within each dosing group as their own control, we were able to analyse whether there was variability in migraine days over the course of a dosing regimen. For all time intervals analysed, the frequency of migraine days was the same in the beginning and end of the dosing period, said Joshua M. Cohen, MD, MPH, FAHS, Global Medical Therapeutic Area Lead for Migraine & Headache, Teva.
This is an important analysis for the migraine community since clinical symptoms often return or worsen before the next dose of many preventive migraine medications is due. Migraine can be a debilitating disease, so evaluating migraine days throughout a dosing regimen can be significant for healthcare providers when considering treatment options. Whenever the brain is exposed to a migraine attack, there is the possibility of increased sensitisation with progressive worsening of the frequency of migraine. A key clinical goal is to limit the amount of time the brain is exposed to migraine to reduce this risk and the number of migraine days impacting a patient before their next dose.
Andrew Blumenfeld, MD, Headache Center of Southern California, The Neurology Center, Carlsbad, CA.
The mean weekly number of migraine days at baseline was 4.0 for patients with CM taking quarterly or monthly AJOVY. For patients with EM, the mean weekly number of migraine days at baseline in the quarterly and monthly AJOVY groups were both 2.3 days.
We’re delighted to announce that ACNR has joined Crossref, and will be allocating DOI’s to new articles. We have also started adding DOI’s to existing articles, but as we have been publishing for almost 20 years we have quite a lot of content to work through!
If you have published an article with us in the past and would like a DOI allocated to it, please email the Publisher Rachael Hansford, who will be happy to organise this for you.
Why have we joined Crossref?
ACNR is fully open access, peer reviewed and widely read around the world.
Joining Crossref will allow us to connect our articles with a global network of online scholarly research, making content even more visible – and linking to other members within article references.
Publish with ACNR
There are no article processing or other charges for ACNR authors or their institutions. If you would like more information about publishing with us, please see https://www.acnr.co.uk/author-guidelines/ or get in touch. We’d love to hear from you!
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 studydemonstrated 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 IItrials7,8 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 2020Virtual 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 partnerOno 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).
Opicapone50 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.
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
H Schmidt et al. A computational biomarker of idiopathic generalized epilepsy from resting state EEG Epilepsia 57: e200-e204 (2016).
S Smith. EEG in the diagnosis, classification, and management of patients with epilepsy Journal of Neurology, Neurosurgery & Psychiatry 76: ii2-ii7 (2005).
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.
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.
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.
[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.
[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.
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.
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
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
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.
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
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