Lyrica fails in Phase IV study in adolescents with fibromyalgia- Pfizer

Pfizer Inc. announced top-line results of a double-blind Phase IV study evaluating the safety and efficacy of Lyrica (pregabalin) Capsules CV in adolescents (ages 12-17 years) with fibromyalgia (FM). 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 (p=0.121). This study was conducted to fulfill a post-marketing commitment required by the FDA when Lyrica was approved for the management of fibromyalgia. The safety and efficacy of pregabalin in pediatric patients have not been established. A total of 107 adolescent patients were enrolled in this Phase 4, 15-week double-blind, randomized, placebo-controlled study from multiple centers across the U.S., Europe and Asia. This study is the first large pharmacological treatment study to be completed in this study population.