Lyrica CR meets Phase III fibromyalgia endpoint

Pfizer Inc. (NYSE:PFE) said once-daily 300-495 mg Lyrica CR pregabalin controlled-release met the primary endpoint vs. placebo in a Phase III trial to treat fibromyalgia. Lyrica CR significantly improved the median time to loss of therapeutic pain response at week 13 vs. placebo (58 vs. 22 days p=0.021). Loss of therapeutic response was defined as a reduction in pain of less than 30% relative to mean baseline pain or withdrawal. Additionally, 54% of patients receiving Lyrica CR had a loss of therapeutic response at week 13 vs. 70.7% for placebo. There were 121 evaluable patients in the double-blind portion of the international trial, which enrolled 441 patients in total.

Pfizer is also evaluating Lyrica CR in an additional Phase III trial in postherpetic neuralgia (PHN), but did not disclose when data are expected. Last week, 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 Lyrica CR as adjunctive treatment each missed the primary endpoint (see BioCentury Extra, Nov. 16). ...