Research Supporting The Role Of Antiepileptic Drug Vimpat® (Lacosamide) (C-V) To Be Highlighted At Upcoming AAN Meeting

Main Category: Epilepsy
Also Included In: Neurology / Neuroscience;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 10 Apr 2010 - 1:00 PDT


The antiepileptic drug (AED) Vimpat® (lacosamide) (C-V) will be the subject of numerous studies and analyses at the 62nd annual American Academy of Neurology (AAN) meeting, taking place at the Metro Toronto Convention Centre in Toronto from April 10-17.

"The breadth and depth of Vimpat data being presented at AAN suggests that the neurology community recognizes the important role of Vimpat in today's epilepsy treatment approach," said James Zackheim, PhD, CNS Medical Director at UCB.

Vimpat tablets are indicated as adjunctive therapy in the treatment of partial-onset seizures in people with epilepsy who are 17 years and older. Vimpat injection is available as an alternative for patients when oral administration is temporarily not feasible. 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.

UCB-Sponsored Vimpat Posters

1. Long-Term Efficacy of Lacosamide for Partial-Onset Seizures: An Interim Evaluation of Completer Cohorts Exposed to Lacosamide for up to 36 Months

Poster P05.179, Thursday, April 15, 2010, 7:30 am, Room 808

Objective: To examine the long-term efficacy of lacosamide in cohorts of patients completing successively longer durations of lacosamide exposure (≥12, 24 and 36 months) in Phase II-III double-blind and/or open-label (OL) extension trials.

2. 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

Poster P05.181, Thursday, April 15, 2010, 7:30 am, Room 808

Objective: Examine long-term safety of lacosamide for partial-onset seizures in Phase II-III double-blind and open-label extension trials.

3. Improvement in Patient-Reported Outcomes Seen in Patients Responding to Lacosamide: Pooled QOLIE-31, SSQ and PGIC Data from 3 Phase II/III Clinical Trials

Poster P05.187, Thursday, April 15, 2010, 7:30 am, Room 808

Objective: To evaluate patient-reported outcome results in three Phase II/III clinical trials of lacosamide, an antiepileptic drug for the adjunctive treatment of partial-onset seizures in adults.

4. Lacosamide Efficacy in Partial-Onset Seizures with and without Secondary Generalization: A Pooled Analysis of Three Phase II/III Trials

Poster P05.186, Thursday, April 15, 2010, 7:30 am, Room 808

Objective: Evaluate the efficacy of lacosamide in individual partial seizure types by change in seizure frequency and proportion of ≥50% responders.

5. Pharmacokinetic Evaluation of Intravenous Lacosamide as Short-Term Replacement for Oral Lacosamide in Partial-Onset Seizures

Poster P05.182, Thursday, April 15, 2010, 7:30 am, Room 808

Objective: To analyze the pharmacokinetic parameters of IV lacosamide administered over infusion durations of 30, 15, or 10 minutes as a short-term replacement (2-5 days) for oral lacosamide in 160 patients receiving lacosamide as part of a long-term, open-label extension trial.

6. 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 P05.178, Thursday, April 15, 2010, 7:30 am, Room 808

Objective: To examine the safety and tolerability of a single intravenous (IV) loading dose of lacosamide infused over 15-minutes followed by oral lacosamide maintenance treatment in subjects with partial-onset seizures (POS) currently taking 1 - 2 AEDs.

7. Outcome of Infants with Prenatal Exposure to Lacosamide during the Clinical Development Program

Poster P05.180, Thursday, April 15, 2010, 7:30 am, Room 808

Objective: To report initial observations of lacosamide exposure during pregnancy in the lacosamide clinical development program.

Select Independent Lacosamide Posters

1. Lacosamide Add-On Treatment: Results of Open Label 6 Months Follow-Up

Poster P05.188, Thursday, April 15, 2010, 7:30 am, Room 808

Objective: We prospectively followed 131 patients (Erlangen cohort A n = 81, Kork cohort B n = 50) treated with add-on lacosamide. Experiences of lacosamide treatment with a follow-up of at least 6 months were reported.

2. Rapid Titration of Lacosamide with Simultaneous Reduction in Concomitant AEDs Is Well-Tolerated and Effective in Reducing Seizures in Patients with Drug-Resistant Partial-Onset Epilepsy

Poster P05.177, Thursday, April 15, 2010, 7:30 am, Room 808

Objective: To determine whether rapid programmed titration of lacosamide to 400 to 700 mg/day with rapid tapering of concomitant antiepilepsy drugs (AEDs) limits side effects and reduces seizures in patients with drug-resistant partial-onset epilepsy.

3. Lacosamide in Brain Tumor Patients

Poster IN10-2.003, Friday, April 16, 2010, 2:30 pm, Reception Hall 104A-D

Objective: The purpose of the study is to investigate a single institution experience with lacosamide in brain tumor patients with seizure disorder.

4. Lacosamide in Refractory Status Epilepticus: A Report of Four Patients

Poster P05.172, Thursday, April 15, 2010, 7:30 am, Room 808

Objective: To report the efficacy of lacosamide in refractory focal status epilepticus (SE) in four patients.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

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® is a registered trademark under license from Harris FRC Corporation.

About Epilepsy

Epilepsy is a chronic neurological disorder affecting approximately 50 million people worldwide and three million people in the U.S. making it more common than multiple sclerosis and Parkinson's disease combined. More than one million U.S. patients continue to experience seizures despite trying two or more antiepileptic drugs (AEDs).

Epilepsy is caused by abnormal, excessive electrical discharges of the nerve cells, or neurons, in the brain. Epilepsy is characterized by a tendency to have recurrent seizures and defined by two or more unprovoked seizures. There are many different seizure types and epileptic syndromes. Roughly 30 percent of people living with epilepsy have either uncontrolled seizures or significant side effects secondary to medication. Almost 60 percent of all epileptic seizures are partial onset.

About UCB

UCB, Brussels, Belgium 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 more than 9,000 people in over 40 countries, UCB produced revenue of EUR 3.1 billion in 2009. UCB is listed on Euronext Brussels (symbol: UCB). U.S. headquarters is located in Atlanta.

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.

Source: UCB

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