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FDA issues complete response letter for eslicarbazepine as treatment for epilepsy

Wednesday, May 12 2010 | Comments

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What's This? The Food and Drug Administration sent Sepracor Inc. a complete response letter regarding the New Drug Application (NDA) for eslicarbazepine acetate, an investigational voltage-gated sodium channel blocker the company is seeking to market as adjunctive therapy for partial-onset seizures in adults with epilepsy.

Sepracor did not specify the contents of the letter other than noting that the regulatory agency said its review was complete but that it would not approve the NDA "at this time." The firm said it plans to meet with the FDA to discuss the contents of the letter and a path forward for gaining approval of the agent.

The drug, which Sepracor is developing under the proposed brand name Stedesa, has been evaluated in 3 Phase III trials that included a total of >1,000 patients who had a history of >=4 partial-onset seizures per month even though they were already receiving 1 to 3 concomitant antiepileptic drugs. In the studies, the participants were randomized to receive eslicarbazepine or placebo for a 2-week titration period and a 12-week maintenance period. This was followed by a 1-year, open-label period.

Sepracor previously noted that eslicarbazepine has the potential to reduce seizure frequency, provide simpler dosage titration, and reduce side effects with once-daily dosing.

The firm filed the NDA in March 2009.

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