NEW YORK CITY (dpa-AFX) - Pfizer Inc. (PFE) reported top-line results from two placebo-controlled studies conducted in China with Lyrica (pregabalin) in patients with postherpetic neuralgia (pain after shingles or PHN) and painful diabetic peripheral neuropathy (pDPN), respectively. The PHN Phase 4 study, A0081276, met its primary endpoint by demonstrating a statistically significant reduction in pain when compared to placebo. Separately, the pDPN Phase 3 study, A0081265, did not meet its primary endpoint, a statistically significant change in endpoint mean pain score relative to placebo.
The PHN study was an eight-week, randomized, double-blind, multi-center, placebo-controlled, post-marketing study evaluating the efficacy, safety and tolerability of pregabalin 300mg/day in the treatment of subjects with PHN. The safety profile was consistent with the known profile for Lyrica.
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