New data on Vimpat® (lacosamide) to be presented at the 65th Annual Meeting of the American Epilepsy Society
For the attention of accredited medical writers
• Guide to data presentations, including patient-reported health-related quality of life, long-term analysis of open-label extension trials, and safety and tolerability for adjunctive IV loading dose
Brussels (Belgium), November 30th, 1830 CET, 2011 – UCB, a leading biopharmaceutical company committed to the development of new epilepsy treatments and research, is proud to sponsor several key sets of Vimpat® (lacosamide) data at the 65th Annual Meeting of the American Epilepsy Society (AES) in Baltimore, Md., December 2 - 6.
“At UCB, we are committed to working towards improving the lives of people living with epilepsy,” said Dr. James Zackheim, Senior Medical Director, Central Nervous System Business Unit, UCB, Inc. “Therefore, we believe it is vitally important to invest in research to better understand the clinical profile of Vimpat®.”
Vimpat® is indicated as an add-on therapy for the treatment of partial-onset seizures in adults with epilepsy. The most common adverse reactions reported in pivotal trials and occurring in 10 percent or more of Vimpat®-treated patients, and greater than placebo, were dizziness, headache, nausea, and diplopia. Additional important safety information for Vimpat® is available at the end of the press release.
Following is a guide to UCB-sponsored posters for Vimpat® being exhibited during the AES annual meeting. To schedule an interview with an investigator, please contact Andrea Levin at 404.483.7329 or Andrea.Levin@ucb.com.
1. Evaluation of Long-Term Treatment with Lacosamide for Partial-Onset Seizures: A Pooled Analysis of Open-Label Extension Trials
Abstract 2.233; Poster Session 2: Sunday, December 4, 8am – 6pm
2. Effect of Long-Term Lacosamide on Patient-Reported Health-Related Quality of Life and Seizure Severity by Seizure Subtype
Abstract 2.244; Poster Session 2: Sunday, December 4 from 8am – 6pm
3. Improved Seizure Severity, Health-Related Quality of Life and Health Status Reported by Patients During Long-Term Treatment with Lacosamide: Analysis of Pooled Open-Label Data
Abstract 2.245; Poster Session 2: Sunday, December 4, 8am – 6pm
4. Lacosamide Added to Concomitant AEDs Grouped by Mechanism of Action – Impact on Patient-Reported Health-Related Quality of Life in Pooled Phase II/III Trials
Abstract 2.246; Poster Session 2: Saturday, December 4, 8am – 6pm
5. Lacosamide Has No Effect on The Enzymatic Activity of CYP3A4
Abstract 1.246; Poster Session 1: Saturday, December 3, 11am – 5:30pm
6. Lacosamide Does Not Alter In Vitro Long-Term Potentiation in Mouse Hippocampal CA1 Area
Abstract 1.266; Poster Session 1: Saturday, December 3, 11am – 5:30pm
Epilepsy is a chronic neurological disorder affecting approximately 50 million people worldwide and three million people in the U.S. Anyone can develop epilepsy; it occurs across all ages, races, and genders. Uncontrolled seizures and medication side effects pose challenges to independent living, learning, and employment, so the goal of epilepsy treatment is seizure freedom with minimal side effects. In the U.S., more than one million patients continue to have seizures despite initial therapy, and more than 800,000 continue to have seizures despite treatment with two or more therapies. ,
Vimpat® tablets and injection were launched in the U.S. in May 2009 as an add-on therapy for the treatment of partial-onset seizures in people with epilepsy who are aged 17 years and older. Vimpat® injection is a short-term replacement when oral administration is not feasible in these patients. Vimpat® oral solution was launched in June 2010. The availability of the oral tablets, oral solution, and intravenous (IV) injection allows for consistent treatment in a hospital setting. The most common adverse reactions occurring in greater than or equal to 10 percent of Vimpat® -treated patients, and greater than placebo, were dizziness, headache, nausea, and diplopia. Additional important safety information for Vimpat® is available at the end of the press release.
In the European Union, Vimpat® (film-coated tablets and solution for infusion) is approved as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalization in patients with epilepsy aged 16 years and older. Vimpat® solution for infusion may be used when oral administration is temporarily not feasible.
The maximum approved daily dose for Vimpat® in the European Union and the U.S. is 400 mg/day.
Important safety information about Vimpat® (C-V) in the U.S.
Warnings and Precautions
Antiepileptic drugs (AEDs) increase the risk of suicidal behavior and ideation. Patients taking Vimpat® should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Patients should be advised that Vimpat® may cause dizziness, ataxia, and syncope. Caution is advised for patients with known cardiac conduction problems, who are taking drugs known to induce PR interval prolongation, or with severe cardiac disease. In patients with seizure disorders, Vimpat® should be gradually withdrawn to minimize the potential of increased seizure frequency. Multiorgan hypersensitivity reactions have been reported with antiepileptic drugs. If this reaction is suspected, treatment with Vimpat® should be discontinued.
Vimpat® oral solution contains aspartame, a source of phenylalanine. A 200 mg dose of Vimpat® oral solution (equivalent to 20 mL) contains 0.32 mg of phenylalanine.
Common Adverse Reactions
The most common adverse reactions occurring in ≥10 percent of Vimpat®-treated patients, and greater than placebo, were dizziness, headache, nausea, and diplopia.
Dosage adjustments are recommended for patients with mild or moderate hepatic impairment or severe renal impairment. The use of Vimpat® in patients with severe hepatic impairment is not recommended.
For full prescribing information on Vimpat®, visit http://www.vimpat.com/prescribing-information.aspx. (Accessed 18th October, 2011)
For more information on Vimpat®, visit www.Vimpat.com or contact UCB at (800) 477-7877.
Vimpat® (C-V) is a Schedule V controlled substance.
Vimpat® is a registered trademark used under license from Harris FRC Corporation.
Important safety information about Vimpat® in the EU and EEA
Vimpat® is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in patients with epilepsy aged 16 years and older. Lacosamide solution for infusion is an alternative for patients when oral administration is temporarily not feasible. Contraindications: Hypersensitivity to the active substance or any of the excipients; known second- or third-degree atrioventricular (AV) block. Special warnings and precautions for use: Treatment with lacosamide has been associated with dizziness which could increase the occurrence of accidental injury or falls. Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicine. Prolongations in PR interval with lacosamide have been observed in clinical studies. Cases with second- and third-degree AV block associated with lacosamide treatment have been reported in post-marketing experience. Lacosamide should be used with caution in patients with known conduction problems or severe cardiac disease such as a history of myocardial infarction or heart failure. Caution should especially be exerted when treating elderly patients as they may be at an increased risk of cardiac disorders or when lacosamide is used in combination with products known to be associated with PR prolongation. Second degree or higher AV block has been reported in post-marketing experience. In the placebo-controlled trials of lacosamide in epilepsy patients, atrial fibrillation or flutter were not reported; however both have been reported in open-label epilepsy trials and in post-marketing experience. Patients should be made aware of the symptoms of second-degree or higher AV block (e.g. slow or irregular pulse, feeling of lightheadedness and fainting) and of the symptoms of atrial fibrillation and flutter (e.g. palpitations, rapid or irregular pulse, shortness of breath). Patients should be counseled to seek medical advice should any of these symptoms occur. Suicidal ideation and behavior have been reported in patients treated with anti-epileptic agents. Therefore patients should be monitored for signs of suicidal ideation and behaviors and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behavior emerge. The solution for infusion contains sodium, which should be taken into consideration for patients on a controlled sodium diet. Effects on ability to drive and use machines: Lacosamide may have minor to moderate influence on the ability to drive and use machines. Lacosamide treatment has been associated with dizziness and blurred vision. Accordingly patients should be advised not to drive a car or to operate other potentially hazardous machinery until they are familiar with the effects of lacosamide on their ability to perform such activities. Laboratory abnormalities: Abnormalities in liver function tests have been observed in controlled trials with lacosamide in adult patients with partial-onset seizures who were taking 1-3 concomitant antiepileptic drugs. Elevations of ALT to ≥3XULN occurred in 0.7% (7/935) of lacosamide patients and 0% (0/356) of placebo patients. Multiorgan Hypersensitivity Reactions: Multiorgan hypersensitivity reactions have been reported in patients treated with some antiepileptic agents. These reactions are variable in expression but typically present with fever and rash and can be associated with involvement of different organ systems. Potential cases have been reported rarely with lacosamide and if multiorgan hypersensitivity reaction is suspected, lacosamide should be discontinued. Undesirable effects: The most common adverse reactions (≥10%) are dizziness, headache, diplopia, and nausea. Other common adverse reactions (≥1%<10%) are depression, confusional state, insomnia, balance disorder, coordination abnormal, memory impairment, cognitive disorder, somnolence, tremor, nystagmus, hypoesthesia, dysarthria, disturbance in attention, vision blurred, vertigo, tinnitus, vomiting, constipation, flatulence, dyspepsia, dry mouth, pruritus, rash, muscle spasms, gait disturbance, asthenia, fatigue, irritability, injection site pain or discomfort (specific to solution for infusion), irritation (specific to solution for infusion), fall, and skin laceration. Refer to the European Summary of Product Characteristics for other adverse reactions and full prescribing information. Date of revision: 15 November, 2011.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000863/WC500050338.pdf (Accessed 18th October, 2011).
Senior Manager, Communications & PR, CNS, UCB, Inc.
Eimear O Brien
Associate Director, Global CNS Communications,
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8 500 people in about 40 countries, the company generated revenue of EUR 3.2 billion in 2010. UCB is listed on Euronext Brussels (symbol: UCB).
Forward Looking Statement
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.
Stay up-to-date on the latest news and information from UCB