Pfizer Inc. (NYSE: PFE) today 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.”
About the Study
The objective of the double-blind, placebo-controlled, multi-center, randomized withdrawal study was to assess the efficacy and safety of pregabalin CR as treatment for patients with fibromyalgia.
The study was composed of 4 phases: baseline (1 week), single-blind (SB) treatment (6 weeks), double-blind (DB) treatment (13 weeks), and a 1-week double-blind taper. Study medication was administered once daily (QD) immediately following the evening meal. During the SB phase, an optimal dose of pregabalin CR (between 300 mg/day to 495 mg/day) was determined. In the DB phase, patients were randomized to continued pregabalin CR treatment at the optimized dose or to matching placebo.