VIMPAT ® is not approved for the treatment of PGTCS. For more information about this study, please consult the abstract.
For Further Information Andrea Levin, Associate Director, U.S. Communications and Public Relations770.970.8352, Andrea.Levin@ucb.com
Amy Condon, Cooney/Waters Group212.886.2212, ACondon@cooneywaters.com
About EpilepsyEpilepsy is a chronic neurological disorder affecting approximately 65 million people worldwide and 2.2 million people in the U.S.—making it more common than autism, cerebral palsy, multiple sclerosis and Parkinson's disease combined. Anyone can develop epilepsy; it occurs across all ages, races and genders and is defined as two or more unprovoked seizures. More than 1 million patients in the U.S. continue to have seizures despite initial therapy. 5,6About VIMPAT ® 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. In the European Union, VIMPAT ® (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 adult and adolescent (16-18 years) patients with epilepsy. 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 ® in the U.S. Warnings and PrecautionsAntiepileptic drugs (AEDs), including VIMPAT ®, 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 and caregivers should also be advised to be alert for these behavioral changes and to immediately report them to the healthcare provider. Patients should be advised that VIMPAT ® may cause dizziness and ataxia. Therefore patients should not drive a car or operate complex machinery until they are familiar with the effects of VIMPAT ® on their ability to perform such activities. Dose-dependent PR interval prolongation has been observed in VIMPAT ® clinical studies in patients and in healthy volunteers. When VIMPAT ® is given with other drugs that prolong the PR interval, further PR prolongation is possible. 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 told to contact their physician should any of these occur. VIMPAT ® should be used with caution in patients with known cardiac conduction problems or with severe cardiac disease. In such patients, obtaining an ECG before beginning VIMPAT ®, and after VIMPAT ® is titrated to steady state, is recommended. VIMPAT ® administration may predispose to atrial arrhythmias (atrial fibrillation or flutter), especially in patients with diabetic neuropathy and/or cardiovascular disease. Patients should be made aware of the symptoms of atrial fibrillation and flutter (e.g. palpitations, rapid pulse, shortness of breath) and told to contact their physician should these symptoms occur. Patients should be advised that VIMPAT ® may cause syncope. VIMPAT ® should be gradually withdrawn (over a minimum of 1 week) to minimize the potential of increased seizure frequency. Multiorgan hypersensitivity reactions have been reported with antiepileptic drugs. If this reaction is suspected, 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 ReactionsIn clinical trials, the most frequently seen adverse reaction with VIMPAT ® was dizziness (31% vs 8% placebo). Other common adverse reactions occurring in >10 percent of VIMPAT ®-treated patients, and greater than placebo, were headache, nausea, and diplopia. VIMPAT ® is a Schedule V controlled substance. Dosage adjustments are recommended for patients with mild or moderate hepatic impairment or severe renal impairment. Use in severe hepatic impairment patients is not recommended. Dose titration should be performed with caution in all renally impaired patients.