GSK Pain Drug Gets Positive Phase IIb Results

GlaxoSmithKline and XenoPort, Inc. achieved positive results from a Phase IIb trial evaluating the safety and efficacy of GSK1838262/XP13512 (gabapentin enacarbil) for neuropathic pain associated with post-herpetic neuralgia (PHN) in adults.

The 14-week, double-blind, placebo-controlled study enrolled 376 subjects with PHN. Subjects were randomized to receive placebo, 1200, 2400 or 3600 mg/day of the drug, dosed twice a day. All doses of GSK1838262 demonstrated statistically significant improvements over placebo on the primary endpoint, which was the change from baseline to the end of maintenance treatment in the 24-hour average pain intensity score.

“We are encouraged by the positive results in this study of GSK1838262 in treating neuropathic pain associated with PHN, which is a debilitating condition for affected patients. We look forward to sharing the full results at a future medical meeting,” said Atul Pande, M.D., senior vice president, GSK Neurosciences Medicines Development Center. “We are currently evaluating the next steps for the development of this compound for the treatment of neuropathic pain.”

The drug was generally well tolerated at all doses in the study. The most common adverse events were dizziness and somnolence; most were mild or moderate in intensity.

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