Pfizer said yesterday that it had has received US Food and Drug Administration approval to market its anti-epileptic, Lyrica (pregabalin) as an add-on treatment of partial onset seizures in adults with epilepsy.
Partial onset seizures represent over half of all seizures in patients with epilepsy, a chronic neurological condition affecting nearly three million Americans.
Lyrica’s efficacy in this new setting was demonstrated in three clinical 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 anti-epileptics. Patients receiving adjunctive treatment with Lyrica experienced a reduction in the frequency of partial seizures by up to 51%.
The FDA gave the thumbs up to Lyrica late in 2004 for the management of diabetic peripheral neuropathy and postherpetic neuralgia [[04/01/05d]]. The product has been approved for neuropathic pain and epilepsy in 46 countries outside of the US, Pfizer said.