• BIAL released opicapone data from seven abstracts at the European Academy of Neurology (EAN) virtual congress • Data from BIPARK-I and II post-hoc analysis show opicapone 50 mg is effective in patients with Parkinson’s disease (PD) regardless of duration of motor fluctuations • Additional data suggest potential for opicapone as first-line adjunctive levodopa/ DDCI (DOPA decarboxylase inhibitor) treatment in patients with motor fluctuations, who cannot be stabilised by levodopa/ DDCI alone
New data was presented at the 6th congress of the European Academy of Neurology, demonstrating the potential for ONGENTYS® (opicapone) to help a wide range of Parkinson’s patients with motor fluctuations.
A new post-hoc analysis of two large multinational trials (BIPARK-I and II1,2) shows that opicapone, a once-daily COMT (catechol-O-methyltransferase) inhibitor, demonstrated efficacy in both patients recently diagnosed with motor fluctuations (duration of motor fluctuations up to 1 year) and long-standing motor fluctuators (duration of more than 1 year) as measured by changes from baseline in absolute OFF- and ON-time versus placebo.3 COMT inhibitor treatment is appropriate for patients taking levodopa where there is evidence of motor fluctuations such as ‘wearing-off’. This can occur earlier in the course of the illness than was previously recognised.4
Dyskinesia was the most frequently reported ‘at least possibly’ related treatment- emergent adverse event. Patients receiving opicapone 50 mg had a lower incidence of dyskinesia if they were recently-diagnosed versus long-standing motor fluctuators.3
Professor Joaquim Ferreira, Professor of Neurology and Clinical Pharmacology at the University of Lisbon, said, “Opicapone demonstrated efficacy in both recently-diagnosed and long-standing motor fluctuations. This reinforces the benefit of opicapone regardless of duration of motor fluctuations and suggests it could be considered as soon as end-of-dose motor fluctuation commences.”
The potential for earlier use of opicapone in some patients was also supported by additional data released at EAN demonstrating efficacy in patients with motor fluctuations treated with levodopa/DDCI-only (that is, without use of dopamine agonists or MAO-B inhibitors) in a posthoc analysis of BIPARK-I and II.5
“BIAL is committed to providing new therapeutic solutions and is proud of the wealth of opicapone data being released at EAN” said António Portela, CEO of BIAL. “Our focus is on providing an effective option for patients on levodopa who may be experiencing motor fluctuations at any stage of treatment. These data, along with real-world evidence from the recently published OPTIPARK study, also presented at EAN, show the potential for opicapone in clinical practice.”
Data on opicapone at the EAN were presented in 11 abstracts, seven of these were sponsored by BIAL:
EPO1224: Ebersbach G et al. Efficacy and Safety of Opicapone in Parkinson’s Disease Patients According to Duration of Motor Fluctuations: Post-Hoc Analysis of BIPARK-I and II3
EPR1141: Ferreira JJ et al. Opicapone as First-Line Adjunctive Levodopa Treatment in Parkinson’s Disease Patients with Motor Fluctuations: Findings from BIPARK-I and II Combined Post-Hoc Analysis5
EPO1182: Antonini A et al. Super-Responders to Opicapone Adjunct Treatment to Levodopa in Parkinson’s Disease Patients with Motor Fluctuations: Combined Post-Hoc Analysis of BIPARK-I and II
EPR2111: Reichmann H et al. Opicapone in Clinical Practice in Parkinson’s Disease Patients with Motor Fluctuations: Findings from the OPTIPARK Study
EPO3148: Rascol O et al. Efficacy of Opicapone in Patients with Parkinson’s Disease with Levodopa Dose Reduction: A Pooled Post-Hoc Analysis of BIPARK-I and II
EPO3141: Poewe W et al. Change in OFF-/ON-Time After Switching from Double-Blind Entacapone or Placebo to Open-Label Opicapone in Patients who Ended the 1-Year BIPARK-I Extension Study on Opicapone 50-mg
EPO3175: Tolosa E et al. Changes Activities of Daily Living and Motor Function in Patients Switching from Entacapone or Placebo to Opicapone who Ended BIPARK-I Extension on Opicapone 50-mg
BIAL announced on 29th April 2020 that the U.S Food and Drug Administration (FDA) has approved ONGENTYS® (opicapone) as an add-on treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes.
We are very pleased to achieve this major regulatory milestone for opicapone, which offers patients living with Parkinson´s disease an effective, once-daily adjunctive treatment option to the gold standard levodopa/dopa-decarboxylase inhibitors preparations. This approval is a landmark in BIAL’s ongoing commitment to the quality of life of Parkinson’s patients and their caregivers. We look forward to working with our partner in the U.S., Neurocrine Biosciences, to make this therapy available to patients.
António Portela, CEO of BIAL.
In February 2017, BIAL and Neurocrine Biosciences entered into an exclusive licensing agreement for the development and commercialisation of opicapone in the U.S. and Canada. The commercial launch of opicapone in the U.S.is expected to occur later in 2020.
The FDA approval of opicapone is supported by data from 38 clinical studies, including two multinational Phase III clinical studies (BIPARK-1 and BIPARK-2). In BIPARK-1, a randomized, double-blind placebo- and active-controlled study, approximately 600 patients with Parkinson’s disease and end-of-dose motor fluctuations received once-daily doses of opicapone (5 mg, 25 mg, or 50 mg), placebo or 200 mg of the COMT (catechol-O- methyltransferase) inhibitor entacapone for 14 to 15 weeks as adjunct to levodopa therapy. In BIPARK-2, which followed a similar study design, approximately 400 patients received once- daily doses of opicapone (25 mg or 50 mg) or placebo.
The primary endpoint for both studies was the change from baseline in absolute time in the OFF state, as assessed by patient diaries. The initial study period in each BIPARK was followed by a one year open-label phase during which all eligible patients received treatment with opicapone. Treatment with opicapone 50 mg was found to be superior to placebo in both studies. The beneficial effects of opicapone 50 mg at reducing the time in the OFF state were accompanied by a corresponding increase in time in the ON state without troublesome dyskinesia. Results from both open-label phases indicated a maintenance of effect for patients previously treated with opicapone 50 mg. Overall, opicapone was found to be generally well tolerated. Primary outcomes from the BIPARK-1 study are published in Lancet Neurology1, with the outcomes from the open-label extension phase published in Neurology2. Primary outcomes from the BIPARK-2 study and the open-label extension are published in JAMA Neurology3.
References
Ferreira J., et al. Lancet Neurol. 2016 Feb;15(2):154-165
Ferreira J., et al. Neurology. 2018 May 22;90(21):e1849-e185 3. Lees A., et al. JAMA Neurol. 2017 Feb 1;74(2):197-206
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 Parkinson’s and extending the ON-time period.
In June 2016, the European Commission authorized Ongentys® (opicapone) as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors (DDCIs) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations. In Europe opicapone is currently marketed in Germany, United Kingdom, Spain, Portugal and Italy.
About BIAL
Founded in 1924, BIAL’s mission is to research, develop and provide therapeutic solutions within the area of health. In the last decades, BIAL has focused strategically on quality, innovation and internationalisation. BIAL is strongly committed to therapeutic innovation, investing more than 20% of its annual turnover into research and development within neurosciences and the cardiovascular system. The company expects to introduce new drugs on the market in the coming years, strengthening its international presence based on proprietary drugs and achieving its goal of supplying innovative products to patients worldwide.
With the non-stop influx of scientific data in neurology, healthcare professionals often struggle to stay up to date on the latest developments by searching through multiple journals and pouring through lengthy articles in search of new advances.
To address the challenge, Biogen Inc. established a single, online platform that aggregates high-quality scientific content in 18 neurology topics, in digestible format. The service was developed by listening to neurologists’ needs through extensive desk research, interviews, prototype testing and ongoing user feedback to ensure the service is relevant and constantly improving.
Called Neurodiem, the non-promotional digital platform from Biogen Inc. is available in six languages and is now live in the United Kingdom, United States, France, Germany, Italy, Spain, Canada and Japan. The scientific information on the platform is entirely objective and independent from Biogen. It is selected, written, and published exclusively by independent scientific writers and editorial partners, who endure ongoing relationships with faculty from academic institutes, and hospitals worldwide. In 2020, the platform features over 3000 daily summaries from key publications, exclusive presentations and interviews from over 70 key medical experts on emerging topics, real-time highlights from 13 international neurology conferences, and access to over 900 full-text articles from renowned neurology journals.
COVID-19 has forced us to use more online resources to keep ourselves up-to-date,” says Rhys Davies, Consultant Neurologist, Liverpool.
I had not previously made much use of online video lectures. However, now I’ve discovered neurodiem.co.uk I find, in particular, its “library” of short lectures from key opinion leaders very useful, in terms of subject selection, content and format!”
More than 7,000 healthcare professionals, including over 4000 neurologists, registered to the platform worldwide in less than one year. For 2020, Biogen Inc. plans on launching the Neurodiem App in the UK to ease access of information on the go. Additionally, the digital team behind the platform is strongly focusing on improving the user experience through advanced personalisation, as a means to provide healthcare professionals in neurology with the best and most convenient service to stay up-to-date in their ever-evolving field.
Learn more on www.neurodiem.co.uk. Neurodiem is free and exclusive to healthcare professionals.
Neurodiem is a service provided by Biogen MA Inc. The information presented on Neurodiem will in no way be selected, modified or altered by Biogen.
The British Neuroscience Association (BNA) is proud to announce that its journal, Brain and Neuroscience Advances, is now indexed in PubMed Central.
The journal plays a major role in the BNA’s credibility in neuroscience campaign, by way of being fully open access, publishing null results and Registered Reports, and using CRedIT and Transparency and Openness Promotion (TOP) badges, all features which help the publishing process support reproducibility, replicability and reliability in science.
Being indexed means researchers will be able to choose a journal that promotes all these things as well as being fully visible on PubMed.
More generally, indexing will mean the journal is instantly accessible to the scientific community, widening its scope and readership. Importantly, it also means that all articles published since its launch, along with all future articles, will now be listed on databases such as PubMed.
Biogen has announced that Fampyra® (fampridine) has been accepted by the Scottish Medicines Consortium (SMC) for use within NHS Scotland. The SMC has approved its use for the improvement of walking in adult patients with multiple sclerosis with walking disability (Expanded Disability Status Scale [EDSS] 4 to 7). This advice applies only in circumstances where the approved NHS Scotland Patient Access Scheme (PAS) is utilised or where the list/contract price is equivalent or lower than the PAS price.1
Fampridine is recommended for use in all subtypes of MS, including relapsing remitting MS (RRMS), secondary progressive MS (SPMS), primary progressive MS (PPMS), and progressive relapsing MS (PRMS) that have either very limited or no treatment options, depending on disease severity.2 Two out of every three patients with MS will develop a degree of disability and walking impairment.2
Dr. Simon Beck, Medical Director, Biogen UK & Ireland, said:
Walking problems affect most people with MS and losing independence as a result of reduced mobility is one of their greatest fears.
Fampridine is the only treatment shown to improve walking ability in people living with MS-related walking disability, so today’s SMC decision could make a real difference to those with mobility challenges in Scotland and their carers, many of whom have been funding their own treatment until now.
Fampridine received a positive funding recommendation from the All Wales Medicine Strategy Group (AWMSG) in December 2019.3 Ireland granted reimbursement of fampridine in September 2015 along with 12 other countries in Europe.
Direct images of a vital brain receptor, 20,000 times smaller than a human hair, have been captured for the first time as part of a world-first study that could allow scientists to unlock more information about neurodegenerative disorders like Alzheimer’s and Parkinson’s.
The international study, led by scientists at the University of Birmingham in collaboration with the University of Würzburg, examined G protein-coupled receptors (GPCRs), specifically the metabotropic glutamate receptor (mGluR4), which mediates the effects of the brain’s main neurotransmitter, in an attempt to establish how the receptors are organised within the brain. While previous research had investigated other types of receptors, very little was known about the organisation of metabotropic glutamate receptors and other GPCRs in the brain.
GPCRs play a fundamental role in regulating virtually all physiological processes in the body, enabling cells to sense external stimuli and communicate with each other. Because of this, they are the targets of at least one third of all drugs on the market. When cells are unable to communicate effectively, conditions such as Parkinson’s, diabetes and heart failure can develop. Understanding how these receptors work under normal conditions is key to the development of effective treatments.
By using an innovative super-resolution microscopy method known as dSTORM this latest study is the first to produce images of mGluR4 receptors in the brain with a resolution of approximately 10 nm, i.e. at least 20-times better than with conventional microscopy. The nanoscale images reveal that the receptors are not randomly located within synapses as previously assumed, but instead are located in highly organised so-called ‘nano-domains’, where they sit very close to the molecules that they regulate. This, researchers suggest, could mean that instead of sending messages to those molecules indirectly, the receptors may physically interact with them to regulate neural communication.
Davide Calebiro, Professor of Molecular Endocrinology at the University of Birmingham and Wellcome Trust Senior Research Fellow, who is lead researcher on the study, said:
By understanding how receptors such as mGluR4 work, we hope to be able to design innovative drugs capable of modulating their function. Our findings could help better understand neurological and neurodegenerative disorders and develop new treatments for diseases such as Parkinson’s or Alzheimer’s.
We hope this research could pave the way to further studies aimed at explaining the functional consequences of the high spatial organisation of synaptic GPCRs we have uncovered. In addition, it will enable other groups to apply similar methods to investigate the nanoscale organisation of molecules involved in other fundamental biological processes.
The next stage of the research is to study the movement of these receptors, as Professor Calebiro adds “So far we have obtained static pictures, but we suspect these structures to be highly dynamic. At our Centre of Membrane Proteins and Receptors (COMPARE), a joint venture with the University of Nottingham, we and other researchers are developing highly innovative methods to track single molecules in real time with unprecedented spatio-temporal resolution. We plan to use these methods to investigate the dynamics of receptors and other signalling molecules in neurons and other cells, such as heart cells.
The full paper ‘Super-resolution imaging reveals the nanoscale organisation of metabotropic glutamate receptors at presynaptic active zones’ was published in Science Advances.
Staff, children and families at The Children’s Trust, a charity that supports children and young people with brain injury and neurodisability, is celebrating after achieving ‘Outstanding’ from the Care Quality Commission (CQC) and Ofsted Care. The news comes as the charity launches a special fundraising appeal in order to keep vital services running.
The CQC report, published last week, stated:
We saw positive interactions between children, young people and staff at all levels. We saw strong evidence of children and young people achieving exceptional outcomes.”
The Ofsted Care report, published last month, stated:
Staff provide the children with high-quality individualised care and support. This results in the children making excellent progress, considering their specific complex health needs. Children have a wonderful experience that enhances their recovery, which includes some children learning to walk and talk again.”
Yet celebrations come as The Children’s Trust faces one of its toughest challenges in its 36-year history. Due to the cancellation of many of its fundraising events, and the closure of its charity shops, it is set to lose hundreds of thousands of pounds in the next few months alone. To keep vital services running the charity needs to raise £7 million a year and it has launched a special appeal to try and recoup the loss so that it can continue to support vulnerable children and families from across the country.
Jayne Cooper, Director of Clinical Services at The Children’s Trust, said:
These are extremely challenging times for our frontline staff and healthcare workers who are wholeheartedly committed to continuing business-as-usual for the children and young people who rely on us. Some children, on 24/7 oxygen or ventilators, require monitoring and care around the clock. We are certainly going to need help from our supporters and the public in order to continue.
“Huge congratulations to a truly fantastic team who work tirelessly to maintain excellent standards at The Children’s Trust. I cannot praise the team enough – you are all heroes.”
A new virtual consultation service – www.doctorinthehouse.net – launched today to provide a free, safe healthcare service that links worried patients to at-home healthcare professionals. The aim is to ease the pressure on the NHS during the COVID-19 outbreak; and to give patients first-hand consultations during the lock-down. This service can scale-up at speed to match the severity of the crisis. Patients can consult on any healthcare issue, freeing up resource in the NHS.
As of today, this free online service is recruiting registered doctors (including GPs, urgent care doctors and specialists) as well as specialist nurses, pharmacists, physiotherapists and other professionals. Accredited professionals are requested to sign up and volunteer their time, from as little as 20-minutes at a time. doctorinthehouse.net is seeking clinicians who are working from home, self-isolating, or between shifts.
The goal of doctorinthehouse.net is to supply 100,000 online assessments and 25,000 online appointments by mobilising over 200 at-home clinicians as soon as possible. The website launched on March 31st 2020.
doctorinthehouse.net
• Is driven by sophisticated scheduling, industry-leading video conferencing and secure patient note handover systems, all supported by a front-end AI diagnostic tool.
DOCTORS – PLEASE GO ONLINE AND REGISTER
For further information, please contact Christian Lewis or David Bond:
ChristianLewisPR@outlook.com 07919 324 890
david.bond@doctorinthehouse.net 07956 624 474
How do medical professionals apply to work with Doctorinthehouse.net and how does the service work?
1. Doctor in the House offers a virtual consultation service, linking ‘at home’ clinicians with patients who cannot otherwise get advice.
2. It checks the applications of all clinicians to ensure that they are appropriately registered with their professional body and that they are suitably insured.
3. It provides the scheduling platform, access to an online video conferencing system, as well as a secure note-taking and patient handover capability, as required.
4. It allows the clinician to make their availability known via a public booking website.
5. Patients can book a 20-minute slot for a free consultation with a professional. Both patient and professional will receive an email with a conference-call link. Ideally the patient will have completed an AI-driven self-assessment in advance.
6. Clinicians can make themselves available for as much or as little time as they wish – from a single 20-minute slot to an entire day. The scheduling platform also allows total flexibility, so that clinicians can specify regular availability, or register themselves day-by-day.
Amazing … I am keen to support however we can
Lord Bethell of Romford, Parliamentary Under Secretary of State Department of Health and Social Care
The Clinical Leader of doctorinthehouse.net Dr DJ Hamblin-Brown says:
This new service will not cost the NHS a penny. By volunteering, or by using doctorinthehouse.net as a patient, you are freeing up NHS resource for someone who needs it. This is the phrase we all hear in an emergency: is there a doctor in the house? This is that moment. Doctors: please come forward and sign up to volunteer your time. The NHS is moving towards an improvement in telemedicine – but not fast enough. We’re here to take up the slack. We’re ready to sign up all healthcare professionals, not just GPs. We will be delivering our first free consultations later this week. We are an online meeting place for two groups who are perfectly matched. Public-spirited healthcare professionals with time to spare, and people who have health worries. We’re bringing doctors into your house.
Allergan receives licence update for BOTOX® (botulinum toxin type A) increasing multidisciplinary team involvement in treatment of debilitating conditions
– Medicines and Healthcare Products Regulatory Agency (MHRA) grants licence update for BOTOX® permitting more healthcare practitioners to administer treatment for people with chronic migraine, post-stroke spasticity and bladder dysfunction
– Licence change marks positive step forward for patients suffering with these debilitating conditions
MARLOW, UNITED KINGDOM – 24 MARCH 2020 – Allergan has announced that the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a licence update for BOTOX® (botulinum toxin type A) across all of its approved indications in the UK. The product licence update makes clear that appropriately trained and qualified healthcare professionals, including specialist nurses and physiotherapists, are able to administer the product to patients. This update should help to remove any barriers in practice that may have been experienced by nurses and other therapists involved with the use of the product across neurology, rehabilitation and urology – ensuring easier access to treatment for these patients.
“The decision to increase the pool of healthcare professionals that can administer the product is positive, not only for the patient but also for us as healthcare practitioners. This announcement acknowledges the significant role that nurses, as part of a multidisciplinary team, play in treating chronic migraine patients, while also making it easier for patients to receive this important therapy.
Susie Lagrata, Headache and Neuromodulation Lead Nurse, The National Hospital for Neurology and Neurosurgery.
“The management and care of patients with muscle spasticity after stroke is complex, with physiotherapists playing an integral role in rehabilitation,” said Dr. Rhoda Allison, Consultant Stroke Physiotherapist, Torbay and South Devon NHS Foundation Trust. “Ensuring that we are included as healthcare practitioners who can administer the product will allow us to more effectively treat patients who can benefit from treatment, and improve access to treatment.”
“This licence update reflects the work being undertaken by urology nurses – as recognised in the recently published supplement to the ‘Getting It Right First Time’ (GIRFT) Urology National Report, which showcases good practice case studies including establishing a nurse-led service. The GIRFT National report highlighted the need to reduce variations, improve productivity, quality and most importantly patient safety within the NHS,” said Julia Taylor, Past President of the British Association of Urological Nurses, Macmillan Consultant Nurse and Clinical Governance Lead, Urology, Salford Royal NHS Foundation Trust. “This is a significant step towards improvements and efficiencies within the NHS through innovations such as nurse-led clinics, which can ultimately lead to the delivery of high quality care whilst maintaining patient safety.”
Nancy Ghattas, UK & Ireland Associate Vice President and Country Manager, Allergan, said:
This licence change reflects the important role that all members of a multidisciplinary team have in disease management, and ensures appropriate access to the product for patients who need it most in the UK.
Important Safety Information
BOTOX® is a prescription medicine that is injected into muscles and used in the treatment of: focal spasticity, including dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, two years of age or older; wrist and hand disability due to upper limb spasticity associated with stroke in adults; ankle and foot disability due to lower limb spasticity associated with stroke in adults; symptomatic relief of blepharospasm, hemifacial spasm and idiopathic cervical dystonia (spasmodic torticollis); prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine); management of bladder dysfunctions in adult patients who are not adequately managed with anticholinergics; overactive bladder with symptoms of urinary incontinence, urgency and frequency; neurogenic detrusor overactivity with urinary incontinence due to subcervical spinal cord injury (traumatic or non-traumatic), or multiple sclerosis.
Adverse Effects: See Summary of Product Characteristics for full information on side effects, including details of uncommon, rare and very rare events. Adverse events usually occur within the first few days following injection and are transient, but may persist for several months or, rarely, longer. Local muscle weakness represents the expected pharmacological action. Localised pain, tenderness and/or bruising may be associated with the injection. Fever and flu syndrome have been reported. Frequency: Defined as Very Common (≥ 1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100). Blepharospasm: Nervous system disorders (Uncommon: Dizziness, facial paresis and facial palsy). Eye Disorders (Very common: Eyelid ptosis. Common: Punctate keratitis, lagophthalmos, dry eye, photophobia, eye irritation and lacrimation increase. Uncommon: Keratitis, ectropion, diplopia, entropion, visual disturbance and vision blurred. Skin and subcutaneous tissue disorders (Common: Ecchymosis.
Uncommon: Rash/dermatitis). General disorders and administration site conditions (Common: Irritation and face oedema. Uncommon: Fatigue). Hemifacial Spasm: as for blepharospasm (as above). Cervical Dystonia: Infections and infestations (Common: Rhinitis and upper respiratory infection). Nervous system disorders (Common: Dizziness, hypertonia, hypoaesthesia, somnolence and headache). Eye Disorders (Uncommon: Diplopia and eyelid ptosis). Respiratory, thoracic and mediastinal disorders (Uncommon: Dyspnoea and dysphonia). Gastrointestinal disorders (Very common: Dysphagia. Common: Dry mouth and nausea). Musculoskeletal and connective tissue disorders (Very common: Muscular weakness. Common: Musculoskeletal stiffness and soreness). General disorders and administration site conditions (Very common: Pain. Common: Asthenia, influenza like illness and malaise. Uncommon: Pyrexia). Paediatric cerebral palsy: Infections and infestations (Very common: Viral infection and ear infection). Nervous system disorders (Common: Somnolence, gait disturbance and paraesthesia). Skin and subcutaneous tissue disorders (Common: Rash). Musculoskeletal and connective tissue disorders (Common: Myalgia, muscular weakness and pain in extremity). Renal and urinary disorders (Common: Urinary incontinence). Injury, poisoning and procedural complications (Common: Fall). General disorders and administration site conditions (Common: Malaise, injection site pain and asthenia). Focal upper limb spasticity associated with stroke: Psychiatric disorders (Uncommon: Depression and insomnia). Nervous system disorders (Common: Hypertonia. Uncommon: Hypoaesthesia, headache, paraesthesia, incoordination and amnesia). Ear and labyrinth disorders (Uncommon: Vertigo). Vascular disorders (Uncommon: Orthostatic hypotension). Gastrointestinal disorders (Uncommon: Nausea and paraesthesia oral). Skin and subcutaneous tissue disorders (Common: Ecchymosis and purpura. Uncommon: Dermatitis, pruritus and rash). Musculoskeletal and connective tissue disorders (Common: Pain in extremity and muscle weakness. Uncommon: Arthralgia and bursitis). General disorders and administration site conditions (Common: Injection site pain, pyrexia, influenza-like illness, injection site haemorrhage and injection site irritation. Uncommon: Asthenia, pain, injection site hypersensitivity, malaise and peripheral oedema). Focal lower limb spasticity associated with stroke: Skin and subcutaneous tissue disorders (Common: Rash). Musculoskeletal and connective tissue disorder (Common: Arthralgia, musculoskeletal stiffness, muscular weakness). General disorders and administration site conditions (Common: Peripheral oedema). Injury, poisoning and procedural complications (Common: Fall). Primary hyperhidrosis of the axillae: Nervous system disorders (Common: Headache and paraesthesia). Vascular disorders (Common: Hot flushes). Gastrointestinal disorders (Uncommon: Nausea). Skin and subcutaneous tissue disorders (Common: Hyperhidrosis (non-axillary sweating) skin odour abnormal, pruritus, subcutaneous nodule and alopecia). Musculoskeletal and connective tissue disorders (Common: Pain in extremity. Uncommon: Muscular weakness, myalgia and arthropathy). General disorders and administration site conditions (Common: Injection site pain. Uncommon: Pain, injection site oedema, injection site haemorrhage, injection site hypersensitivity, injection site irritation, asthenia and injection site reactions). Chronic Migraine: Nervous system disorders (Common: Headache, migraine, facial paresis). Eye disorders (Common: Eyelid ptosis. Uncommon: Eyelid oedema). Skin and subcutaneous tissue disorders (Common: Pruritus, rash. Uncommon: Pain of skin). Musculoskeletal and connective tissue disorders (Common: Neck pain, myalgia, musculoskeletal pain, musculoskeletal stiffness, muscle spasms, muscle tightness, muscular weakness. Uncommon: Pain in jaw). Generaldisorders and administration site conditions (Common: Injection site pain). Gastrointestinal disorders (Uncommon: Dysphagia). Overactive bladder: Infections and infestations (Very common: Urinary tract infection. Common: Bacteriuria). Renal and urinary disorders (Very common: Dysuria. Common: Urinary retention, residual urine volume, pollakiuria, leukocyturia). Urinary incontinence due to neurogenic detrusor overactivity: Infections and infestations (Very common: Urinary tract infection). Psychiatric disorders (Common: Insomnia). Gastrointestinal disorders (Common: Constipation). Musculoskeletal and connective tissue disorders (Common: Muscular weakness, muscle spasm). Renal and urinary disorders (Very common: Urinary retention. Common: Haematuria, bladder diverticulum). General disorders and administration site conditions (Common: Fatigue, gait disturbance). Injury, poisoning and procedural complications (Common: Autonomic dysreflexia, fall). Please see BOTOX® Summary of Product Characteristics for full product information.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.
With colleagues and commercial operations located in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day. For more information, visit Allergan’s website at https://www.allergan.co.uk/.
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