Pfizer’s Phase 4 Study Fails to Meet Primary Endpoint

Pfizer announced top-line results of a double-blind phase 4 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. This study was conducted to fulfill a postmarketing commitment required by the US Food and Drug Administration (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 US, Europe, and Asia. A spokesperson for the Pfizer Global Innovative Pharmaceutical business stated that the study results “…do not change the established benefit of Lyrica for its approved indications, including fibromyalgia in adults.” Lyrica is currently approved for 5 indications in the US, of which 4 are in the therapeutic area of pain. These indications are neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia (pain after shingles), neuropathic pain associated with spinal cord injury, fibromyalgia, and partial onset seizures in adults with epilepsy who take 1 or more drugs for seizures.

Read a news report about the study results here.

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