Pfizer (PFE) Repors Statistically Significant Data from Pregabalin CR Phase 3

Pfizer, Inc. (NYSE: PFE) announced that top-line results of a double-blind, Phase 3 study evaluating pregabalin controlled-release (CR) formulation in patients with fibromyalgia indicate that pregabalin CR had a statistically significant positive effect compared to placebo in the primary endpoint, time to loss of therapeutic response (LTR). Fibromyalgia is a common pain condition in the United States, affecting more than five million Americans. It is characterized by chronic widespread pain and tenderness lasting for three or more months.

This study is the second of three Phase 3 studies of the pregabalin CR formulation to report top-line findings, which will ascertain the potential use of pregabalin as a once-a-day therapy. The top-line results of the first study in adults with partial onset seizures with epilepsy did not meet its primary endpoint. The final study in post-herpetic neuralgia is ongoing. Pfizer will analyze further results of all three studies once data are available.

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