Top-line results from Pfizer's pregabalin CR formulation Phase 3 study on fibromyalgia

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.

"Collectively, the results of these controlled release studies will allow us to better understand the potential of a once-a-day pregabalin treatment regimen," said Steven J. Romano, M.D., senior vice president, head, Medicines Development Group, Global Primary Care Business Unit, Pfizer Inc. "Reducing the number of times patients need to take their medicine per day while maintaining the same efficacy and safety profile could potentially provide a greater convenience and the potential to enhance treatment adherence and outcomes."

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