Lyrica CR misses Phase III epilepsy endpoint

Pfizer Inc. (NYSE:PFE) said once-daily 165 and 330 mg Lyrica CR pregabalin controlled-release as adjunctive treatment of partial onset seizures in adults with epilepsy each missed the primary endpoint in a Phase III trial. Specifically, both doses missed the primary endpoint of reducing the log-transformed 28-day seizure rate for all partial onset seizures collected during the 14-week double-blind treatment period from baseline vs. placebo (p=0.907 for high-dose; low-dose p-value not disclosed). Pfizer did not disclose detailed data for the primary endpoint, but said the non-significant reduction in seizure frequency may be due to a higher than expected placebo response. Responder rates, defined as the proportion of patients with a 50% or greater reduction in seizure frequency from baseline, were 37.8% for low-dose pregabalin CR, 45.9% for high-dose pregabalin CR and 35.8% for placebo. ...