Lyrica CR pregabalin controlled-release: Phase III data

Top-line data from 121 evaluable patients in the double-blind portion of an international Phase III trial showed that once-daily 300-495 mg pregabalin CR met the primary endpoint of improving median time to LTR, defined as a reduction in pain of <30% relative to mean baseline pain or withdrawal, at week 13 vs. placebo (58 vs. 22 days p=0.021). LTR occurred in 54% of patients receiving pregabalin CR vs. 70.7% for placebo. Pregabalin CR was well tolerated with dizziness, somnolence, peripheral edema, insomnia, headache, fatigue, nausea, weight increase, blurred vision, dry mouth and disturbance in attention reported as the most common adverse events. The trial included 4 phases - a 1-week baseline screening period; a 6-week single-blind treatment phase to determine each patient's optimal dose of pregabalin CR (between 300-495 mg); a 13-week double-blind treatment phase with placebo or optimal dose; and a 1-week taper phase. The trial enrolled 441 patients, of which 122 completed the single-blind treatment phase and advanced into the double-blind phase.

Pfizer is also evaluating pregabalin CR in an additional Phase III trial in postherpetic neuralgia (PHN), but did not disclose when data are expected. Last month, the pharma reported top-line data from a Phase III trial to treat partial onset seizures in patients with epilepsy showing 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 vs. placebo (see BioCentury, Nov. 19). ...