UCB's Vimpat® (Lacosamide) Approved by FDA as Add-on Therapy for Partial Onset Seizures in Adults

UCB recently announced that the Food and Drug Administration (FDA) has approved Vimpat® (lacosamide), a new antiepileptic drug (AED). Vimpat® is approved for use as an add-on therapy for the treatment of partial-onset seizures in people with epilepsy who are 17 years and older.  

"Having a new antiepileptic drug option may offer adults with partial onset seizures the chance to obtain seizure control. There is still a need for new therapies to help patients achieve this goal," said lead investigator Steven S. Chung, M.D., Director of Clinical Epilepsy Research at Barrow Neurological Institute in Phoenix.

In preclinical studies, Vimpat®'s mechanism of action has been shown to involve the modulation of sodium channel activity in the nervous system. Sodium channels play a crucial role in regulating the activity of the nervous system to help nerve cells communicate. Sometimes sodium channels become abnormally overactive and nerve cells become too excited, which may produce a seizure. Vimpat®'s mechanism of action is thought to reduce this sodium channel over-activity by prolonging the longer lasting resting state of the channel, a different action compared with current sodium channel blocking drugs. This action then regulates the activity of over-excited nerve cells, which may contribute to the control of seizures. 

In preclinical studies, Vimpat® has also been shown to bind to the collapsin response mediator protein-2 (CRMP-2), an important target that affects the way that nerves differentiate and grow. The precise nature of the interaction between Vimpat® and CRMP-2 and between CRMP-2 and seizure control is not known.

Patients began experiencing a reduction in seizures during the titration phase and maintained or improved seizure control throughout the studies. The most common side effects reported in these trials included double vision, headache, dizziness and nausea. More than half of the patients completing the clinical trials opted to continue treatment, some for as long as five years.

Vimpat® will be designated a controlled substance. The recommended classification is still under review by authorities, however this is expected to be finalized in early 2009 at which time Vimpat® will be available in U.S. pharmacies. 

At the end of August 2008, the European Commission approved Vimpat® for the adjunctive treatment of partial onset seizures with or without secondary generalization in patients with epilepsy, age 16 and over. In September Vimpat® was launched in Germany and the UK with other European countries to follow in the coming months.

Reviewed by Epilepsy Foundation Professional Advisory Board Member, Brian Alldredge, PharmD, Professor of Clinical Pharmacy & Neurology & Associate Dean, Academic Affairs, School of Pharmacy, University of California, San Francisco