Pfizer's Lyrica fails in adolescents with fibromyalgia
US pharma giant Pfizer (NYSE: PFE) today released disappointing 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 US Food and Drug Administration when Lyrica was approved for the management of fibromyalgia. The safety and efficacy of pregabalin in pediatric patients have not been established.
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