Pfizer 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). Pregabalin is an alpha2-delta ligand.
The objective of the 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 300mg/day–495mg/day) was determined. In the DB phase, patients were randomized to continued pregabalin CR treatment at the optimized dose or to matching placebo. A total of 441 subjects were enrolled into the SB phase. Of the 441 subjects, 122 (28%) completed SB, had ≥50% pain response (ie, ≥50% reduction in pain compared to baseline) and were randomized into DB.
The primary endpoint, defined as the time to loss of therapeutic pain response during DB (LTR; <30% pain response relative to the SB baseline mean pain or withdrawal due to lack of efficacy or adverse events), occurred in 34 of 63 (54%) patients in the pregabalin group as compared with 41 of 58 (70.7%) subjects in the placebo group. The median time from randomization to LTR was 58 days in the pregabalin group and 22 days in the placebo group. The difference between the treatments was statistically significant (log-rank P-value=0.021).
The immediate-release formulation of Lyrica (pregabalin capsules, oral solution, CV) is already approved for five indications: neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, neuropathic pain associated with spinal cord injury, fibromyalgia and partial onset seizures in adults with epilepsy who take one or more drugs for seizures.
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