Pfizer Says Phase 4 Lyrica Study Fails To Meet Main Goal

(RTTNews) - Pfizer Inc. (PFE) on Thursday announced top-line results of a double-blind Phase 4 study evaluating the safety and efficacy of Lyrica, or pregabalin, Capsules CV in adolescents with fibromyalgia.

The drugmaker said the primary endpoint of the study was not achieved as there was not a statistically significant difference between pregabalin and placebo in mean pain score.

The treatment difference was 0.66 points, which reflects an improvement of 1.60 points from baseline for pregabalin-treated patients and 0.94 points for placebo.

The study was conducted to fulfill a post-marketing commitment required by the U.S. Food and Drug Administration when Lyrica was approved for the management of fibromyalgia.

Lyrica is currently approved for five indications in the U.S., of which four are in the therapeutic area of pain. Those indications include neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, neuropathic pain associated with spinal cord injury, fibromyalgia and partial onset seizures in adults with epilepsy who take one or more drugs for seizures.