Pfizer's Lyrica Receives Approval as Epilepsy Add-On Treatment

Pfizer has received FDA approval to market Lyrica for adjunctive treatment of partial onset seizures in adults with epilepsy.

Partial onset seizures represent more than half of all seizures in patients with epilepsy, according to Pfizer, which said Lyrica (pregabalin) would be available in pharmacies for the new indication in the fall. The efficacy of Lyrica was established in three double-blind, controlled trials involving 1,052 patients. At the start of treatment with Lyrica, patients experienced approximately 10 seizures a month despite taking one to three other antiepileptic medications. Patients receiving adjunctive treatment with Lyrica experienced a reduction in the frequency of partial seizures by up to 51 percent.

The FDA approved Lyrica in December 2004 for the management of diabetic peripheral neuropathy and postherpetic neuralgia.

In a research note issued last month, Deutsche Bank analyst Barbara Ryan said Lyrica should launch in September and generate sales of roughly $200 million in 2005 and $450 million in 2006.