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Highlights include:
"As a clinician, it is encouraging to know that the ongoing clinical program for VimpatŪ has yielded safety and efficacy data totaling almost 3,000 patient years of exposure," said Dr. Jacqueline French, Director of the Clinical Trials Consortium at the Comprehensive Epilepsy Center at New York University Langone Medical Center.
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VimpatŪ was 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 17 years and older, and is available as oral tablets and as an intravenous (IV) infusion to allow for consistent treatment in a hospital setting. In Europe, VimpatŪ (film-coated tablets, syrup, 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. VimpatŪ has a novel mechanism of action that is different from all currently available AEDs, although the precise mechanism by which VimpatŪ exerts its antiepileptic effect in humans is not yet clear.
Summary of VimpatŪ Data Presented at 2009 AES Annual Meeting
Abstract: Long-term Efficacy of Lacosamide for Partial-Onset Seizures: An Interim Evaluation of Completer Cohorts Exposed to Lacosamide for up to 36 Months
This analysis of phase II/III open-label extension trials demonstrated that lacosamide produced long-term, sustained efficacy in patients with partial-onset seizures who completed 6, 12, 18, 24, 30, or 36 months of treatment. Researchers noted that given the study's "nested cohort" design, with each cohort including patients remaining from the shorter-duration cohort, the expected attrition of non-responders is accounted for, and efficacy findings reflect real-world use.
Poster Session 2, Sunday, December 6, 5:00 pm - 6:00 pm, Hall D, Level 2 (Abstract 2.227) Elinor Ben-Menachem(1), Jacqueline French(2), Jouko Isojarvi(3), David Hebert(3), Pamela Doty(3) (1)Sahlgrenska Academy University of Gothenburg, Gothenburg, Sweden; (2)NYU Comprehensive Epilepsy Center, New York, New York; (3)SCHWARZ BIOSCIENCES (a member of the UCB Group), Raleigh, North Carolina
Abstract: Long-term Safety and Tolerability of Lacosamide for Partial-Onset Seizures: An Interim Evaluation of Patients Exposed to Lacosamide in Double-Blind and Open-Label Trials
This analysis of 1,327 patients exposed to lacosamide during double-blind or open-label extension trials demonstrated that the incidence of adverse events, as well as vital signs and clinical laboratory and ECG findings, among patients taking lacosamide for a median duration of 700 days, or almost 2 years (minimum duration: 1 day; maximum duration: 2,437 days, or 6.7 years), were similar to those reported with short-term use. The dose most commonly used for the longest period of time was 400 mg/day.
Poster Session 2, Sunday, December 6, 4:00 pm - 5:00 pm, Hall D, Level 2 (Abstract 2.231) W. Rosenfeld(1), F. Rosenow(2), J. Isojarvi(3), D. Hebert(3), P. Doty(3) (1)The Comprehensive Epilepsy Care Center for Children and Adults, St. Louis, Missouri; (2)Interdisciplinary Epilepsy Center, Department of Neurology, Philipps-University, Marburg, Germany;(3)SCHWARZ BIOSCIENCES (a member of the UCB Group), Raleigh, North Carolina
Abstract: Preliminary Evaluation of the Risk of Cognitive Adverse Events in Lacosamide Clinical Trials for Adjunctive Treatment of Partial Onset Seizures
This preliminary analysis of spontaneously reported TEAEs potentially related to cognitive function showed that rates of these TEAEs among patients taking therapeutic doses of VimpatŪ were dose-dependent. Researchers noted that these findings are preliminary, and should be confirmed with formal neuropsychological testing.
Poster Session 2, Sunday, December 6, 5:00 pm - 6:00 pm; Hall D, Level 2 (Abstract 2.228) D. Hebert(1), C. Helmstaedter(2), A. M. Kanner(3), J. Isojarvi(1), A. Eggert(4), P. Doty(1) (1)SCHWARZ BIOSCIENCES (a member of the UCB Group), Raleigh, North Carolina ; (2)Bonn University Hospital, Bonn, Germany; (3)Rush University Medical Center, Chicago, Illinois; (4)UCB, Inc., Atlanta, GA
Abstract: Effect of the New Anticonvulsant Drug Lacosamide on Persistent Na+- Current and Firing Behavior of Hippocampal Pyramidal Cells
This animal study examined the neurological impact of lacosamide on persistent sodium currents (INa,P) in the brain cells that regulate excitation - hippocampal CA1 pyramidal neurons. Findings suggest that lacosamide blocks persistent sodium currents in a manner that differs from that of carbamazepine, which acts on the sodium channel in a manner shared by traditional sodium channel agents.
Poster Session 2, Sunday, December 6, 4:00 pm - 5:00 pm; Hall D, Level 2 (Abstract 2.203) Mischa Uebachs(1), Thoralf Opitz(1), Thomas Stoehr(2), Isabelle Niespodziany(3), Christian Wolff(3), Heinz Beck(1)(1)University of Bonn, Dept. of Epileptology, Bonn, Germany; (2)bitop AG Stockumer Str. 28 58453 Witten, Germany; (3)UCB Pharma, Brussels, Belgium
Additional UCB-supported VimpatŪ studies to be presented at the AES meeting include:
Efficacy of Adjunctive Lacosamide in Patients with Partial-onset Seizures and Prior Surgical Interventions for Epilepsy Poster Session 2, Sunday, December 6, 5:00 pm - 6:00 pm, Hall D, Level 2 (Abstract 2.233) S. Benbadis(1), C. Elger (2), D. Hebert(3), J. Isojarvi(3) (1)University of South Florida, Tampa General Hospital, Tampa, Florida; (2)University of Bonn Medical Center, Bonn Germany (3)SCHWARZ BIOSCIENCES (a member of the UCB Group), Raleigh, North Carolina
Minimally Important Change in QOLIE-31 Scores: Estimates from Three Placebo-Controlled Lacosamide Trials in Patients with Partial Onset Seizures Poster Session 2, Sunday, December 6, 4:00 pm - 5:00 pm, Hall D, Level 2 (Abstract 2.224) Christine de La Loge(1), Simon Borghs(2), Knut Mueller(3), Joyce Cramer(4)(1)UCB Pharma, Brussels, Belgium; (2) Business & Decision Life Sciences, Brussels, Belgium; (3)UCB Pharma, Monheim, Germany; (4)Yale University, Orange, CT, USA
Pharmacokinetic Evaluation of Intravenous Lacosamide as Short-Term Replacement for Oral Lacosamide in Partial-Onset Seizures Poster Session 2, Sunday, December 6, 4:00 pm - 5:00 pm, Hall D, Level 2 (Abstract 2.223) Willi Cawello, PhD(1), Gregory Krauss, MD(2), Melissa Brock, PharmD(3), Andrea Eggert PharmD, BCPP(4) (1)SCHWARZ BIOSCIENCES, GmbH, A Member of the UCB Group of Companies, Monheim, Germany; (2)Department of Neurology, Johns Hopkins Epilepsy Center, Baltimore, Maryland, United States, 21287; (3)SCHWARZ BIOSCIENCES, Inc., RTP, NC, United States; (4)UCB, Inc., Atlanta, GA, United States
A Multicenter, Open-Label Trial to Assess the Safety And Tolerability of a Single Intravenous Loading Dose of Lacosamide Followed by Oral Maintenance as Adjunctive Therapy in Subjects with Partial-Onset Seizures: An Interim Report Poster Session 2, Sunday, December 6, 4:00 pm - 5:00 pm, Hall D, Level 2 (Abstract 2.222) Nathan B. Fountain(1), Gregory Krauss(2), Jouko Isojarvi(3), Deanne Dilley(3), Pamela Doty(3 (1)University of Virginia, Charlottesville, Virginia; (2)John Hopkins University, Baltimore, Maryland; (3)Schwarz Biosciences (a member of the UCB Group), Raleigh, North Carolina
Outcome of Infants with Prenatal Exposure to Lacosamide During the Clinical Development Program Poster Session 2, Sunday, December 6, 5:00 pm - 6:00 pm, Hall D, Level 2 (Abstract 2.235) Jouko Isojarvi(1), Christina Williams(1), Pamela Doty(1) (1)SCHWARZ BIOSCIENCES (a member of the UCB Group), Raleigh, North Carolina
Important safety information about VimpatŪ in the U.S.
VimpatŪ (lacosamide) is a medicine that is used with other medicines to treat partial-onset seizures in patients 17 years of age and older with epilepsy. VimpatŪ is generally well-tolerated, but may not be for everyone. Patients should discuss with their doctor if VimpatŪ is right for them.
The most common side effects with VimpatŪ are dizziness, headache, nausea and double vision. VimpatŪ may also cause problems with coordination and balance. Patients should not drive, operate machinery or do other dangerous activities until they know how VimpatŪ affects them. Patients should not stop taking VimpatŪ without first talking to their doctor. Stopping VimpatŪ suddenly can cause serious problems. VimpatŪ could make patients feel faint. Patients should tell their doctor if they have a heart condition or if they are taking other medicines that affect the heart. In rare cases, VimpatŪ may cause reactions that could affect the heart, liver or kidney. The patient should contact their doctor immediately if they are tired, have jaundice (yellowing of skin or eyes), and have dark urine. Antiepileptic drugs, including VimpatŪ, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Patients should call their healthcare provider right away if they have new or worsening symptoms of depression, any unusual changes in mood or behavior, or suicidal thoughts, behavior, or thoughts about self harm that they have never had before or may be worse than before. To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1-866-822-0068 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full prescribing information at http://www.vimpat.com/pdfs/PI.pdf.
Important safety information about VimpatŪ in Europe
VimpatŪ is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. VimpatŪ solution for infusion is an alternative for patients when oral administration is temporarily not feasible. Contraindications: Hypersensitivity to the active substance or to peanuts or soya or to 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. 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. Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents. Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. Undesirable effects: The most common adverse reactions (greater than 10 percent) are dizziness, headache, diplopia, and nausea. Other common adverse reactions (1-10 percent) are depression, balance disorder, coordination abnormal, memory impairment, cognitive disorder, somnolence, tremor, nystagmus, vision blurred, vertigo, vomiting, constipation, flatulence, pruritus, gait disturbance, asthenia, fatigue, fall, and skin laceration. Refer to the European Summary of Product Characteristics for full prescribing information. http://www.emea.europa.eu/humandocs/PDFs/EPAR/vimpat/emea-combined-h863en.pdf (Accessed 02.03.09)
VimpatŪ is a registered trademark under license from Harris FRC Corporation.
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical company dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing approximately 10,000 people in over 40 countries, UCB generated revenue of EUR 3.6 billion in 2008. UCB is listed on Euronext Brussels (symbol: UCB).
Forward-looking statements
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.
-- VimpatŪ was associated with sustained efficacy as measured by percent change in seizure frequency and responder rates (percent of patients reporting seizure reduction rates of 50 percent or greater) among patients on active treatment for 6, 12, 18, 24, 30, or 36 months. -- In an analysis of patients taking VimpatŪ for a median of two years, no new types of treatment-emergent adverse events (TEAEs) occurred with long-term use, and rates of TEAEs were similar to those observed during the pivotal clinical trials. -- A preliminary retrospective analysis of VimpatŪ phase II/III studies reported that rates of spontaneously reported adverse events potentially related to cognition among VimpatŪ patients were dose-dependent and not significantly different from those observed in patients taking placebo. -- Experiments on the brain cells involved in epileptic seizures suggest that VimpatŪ exerts a novel effect on sodium channels, different from traditional sodium channel AEDs.
SOURCE UCB
