New Epilepsy Treatment Receives FDA Approval

Greg Lavine

BETHESDA, MD 04 November 2008—FDA recently approved a new drug to help treat partial-onset seizures in patients with epilepsy, according to the company marketing the product, UCB Inc.

The Belgium-based pharmaceutical company created the drug, with the generic name lacosamide, in tablet and intravenous infusion forms, the company said in a press release. Marketed as Vimpat, the drug is intended as an add-on therapy for patients 17 years or older.

"Having a new antiepileptic drug option may offer adults with partial-onset seizures the chance to obtain seizure control," lead investigator Steven Chung of the Barrow Neurological Institute in Phoenix, Arizona, said in a press release. "There is still a need for new therapies to help patients achieve this goal."

The company said it is not sure about the exact mechanism for why the drug helps prevent partial-onset seizures. Scientists believe the mechanism involves sodium-channel activity in the nervous system.

Sodium channels, along with nerve cells, can become overactive and prompt a seizure. According to the company, scientists speculate that the drug may help control overactivity of the sodium channels.

In clinical trials involving approximately 1300 people, patients taking the drug had about half as many partial-onset seizures, the company said.

Among the most common adverse events were diplopia, headache, dizziness, and nausea.

Tablet and intravenous doses are bioequivalent, so they do not have to be adjusted when switching between formulations. The intravenous option is available for when the patient is unable to swallow a tablet, according to prescribing information (PDF).

Dosing should begin at 50 mg twice daily and can be increased to a daily dose of up to 400 mg daily, given as two divided doses. Injections do not have to be diluted and should be administered over 30 to 60 minutes, according to the company.

Dosage strengths for tablets are 50, 100, 150, and 200 mg. The intravenous form of the drug comes in 200-mg/20-mL single-use vials.

The company plans to make the drug available early in 2009.