Pregabalin controlled-release: Phase III data
Top-line data from an international Phase III trial in patients with epilepsy showed that once-daily 165 and 330 mg pregabalin CR as adjunctive treatment each 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% 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.
Both doses of pregabalin CR were well tolerated with dizziness, weight increase and somnolence reported as the most common adverse events. The trial included 4 phases - an 8-week baseline screening period; a 2-week double-blind, dose-escalation phase; a 12-week double-blind, fixed-dose maintenance phase; and a 1-week taper phase. Pfizer is also evaluating pregabalin CR in 2 additional Phase III trials in fibromyalgia and postherpetic neuralgia (PHN), respectively, but did not disclose when data are expected. ...