Depomed, Inc. announced top-line results from a Phase 3 trial of DM-1796 (gabapentin extended-release) for the treatment of pain associated with postherpetic neuralgia (PHN). This randomized, double-blind, placebo-controlled study involved 452 PHN patients. Patients in the study were randomized into two treatment arms: placebo or 1800 mg of DM-1796 dosed once-daily. The primary endpoint measured pain scores from baseline to the end of a ten-week treatment period using the numerical Likert pain scale. Secondary objectives included an assessment of changes from baseline in sleep interference, and additional patient and clinician assessments of pain and quality of life. In the study, DM-1796 achieved a statistically significant reduction in pain associated with PHN versus placebo using the baseline observation carried forward (BOCF) method required by FDA.
DM-1796 is an investigational extended release, once-daily tablet formulation of gabapentin for the treatment of PHN.
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