Encouraging data for Eisai epilepsy drug
pharmafile | August 24, 2010 | News story | Sales and Marketing | Eisai, epilepsy, perampanel, phase III, seizures, study 306
A new phase III study for Eisai’s perampanel (E2007) suggests the first-in-class treatment is effective as an adjunctive treatment of partial seizures in epilepsy patients.
The drug is a highly selective non-competitive AMPA-type glutamate receptor antagonist, and if approved, will add to the company’s presence in the therapy area.
The trial, named Study 306, showed perampanel was well-tolerated and effective in reducing median seizure frequency and increasing responder rates versus placebo, the primary outcome measures in the US and the EU, respectively.
The findings were statistically significant in the two higher dose arms of the three arm trial, in 4 mg and 8 mg doses compared to placebo. A linear trend for dose response was also statistically significant.
The global study consisted of 706 patients randomised to placebo or one of three perampanel doses. Patients started on 2 mg doses of perampanel, then remained on 2 mg or increased dosage weekly in 2 mg increments to their randomised doses of 4 mg or 8 mg.
The study is the first in a series of phase III trials for perampanel, with two more global phase III studies for adjunctive therapy in partial seizures underway.
Eisai plans to submit simultaneously in the US and EU in its fiscal year 2011.
The company already has three other epilepsy treatments on the market in Europe, Zonegran, Zebinix and Inovelon.
Eisai gained approval for Zebinix, a novel once-daily treatment in 2009. Zebinix (eslicarbazepine acetate) was developed by Bial and is licensed to Eisai for co-promotion in Europe. Sepracor has the marketing rights in the US and Canada, but the FDA is demanding further clinical data before approving the drug.
The epilepsy market is undergoing a wave of patent expiries, which will make it difficult for new entrants to the therapy area. GSK’s blockbuster Lamictal has already gone off patent, while Johnson & Johnson’s Topomax will follow in 2012.
Andrew McConaghie
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