Phase III Study Supports Lacosamide as Epilepsy Monotherapy

UCB Pharma submitted a supplement to its new drug application for lacosamide (Vimpat) that would allow it to serve as monotherapy in patients with partial-onset seizures.

A UCB Pharma-supported Phase III study suggests that the company’s lacosamide (Vimpat) antiepileptic drug is safe and effective monotherapy for patients with partial-onset seizures, supporting a supplement to its new drug application for the product.

Launched in tablet and infusible solution in May 2009, lacosamide therapy is currently approved as an adjunctive therapy for adults with partial-onset seizures. UCB also brought an oral solution to market in June 2010.

“We know that there are many patients who can gain significant control with monotherapy,” Kelly Simontacchi, PhD, central nervous system medical director at UCB, said in an interview with Pharmacy Times. “As a general approach in epilepsy, if a patient can be managed on 1 AED [antiepileptic drug], that’s preferable. (But) There are patients who will require multiple AEDs or combination therapy.”

The study, which was presented at the 67th Annual Meeting of the American Epilepsy Society on December 6 through 10, 2013, analyzed conversion to lacosamide monotherapy in adults on 1 or 2 antiepileptic drugs.

The double-blind randomized trial included participants 16 to 70 years of age who experienced 2 to 40 partial-onset seizures during a 28-day period. The patients initiated lacosamide monotherapy during a 3-week titration phase, and ultimately received 300 or 400 mg of therapy per day. After titration, the participants went through a 6-week withdrawal of their background antiepileptic drug therapy, and 10-week lacosamide monotherapy period.

Researchers divided participants into a 425-participant safety set, which included all patients who received more than 1 dose of lacosamide monotherapy, and a 383-participant full analysis set, who completed lacosamide titration, received more than 1 dose of lacosamide, and began withdrawing background antiepileptic drugs.

Levetiracetam, carbamazepine, and lamotrigine were the most commonly prescribed background therapies, the researchers noted.

The predicted exit rate for 400 mg lacosamide monotherapy was statistically significantly lower than the historical control’s exit rate at the end of the study period.

The median monotherapy duration was 71 days for both the 300- and 400-mg groups. The majority of participants and clinicians reported improvements according to global impression of change assessments.

Only 28.9% of participants met at least 1 study exit criteria, which included a 2-fold or greater increase in average monthly partial seizure frequency; a 2-fold or greater increase in consecutive 2-day partial seizure frequency compared with baseline measurements; occurrence of a single tonic-clonic seizure if none occurred 6 months prior to the study; longer or worse overall seizure duration, frequency, type, or pattern; or status epilepticus or onset of serial or cluster seizures, the researchers noted.

Common treatment-related adverse events in both participant groups included dizziness, nausea, and headache.

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