GlaxoSmithKline (GSK) And XenoPort (XNPT) Announce Phase II Results for GSK1838262
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- CORRECTING and REPLACING GlaxoSmithKline and XenoPort Announce Extension of GSK1838262 (XP13512) FDA Review Date to February 9, 2010
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GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) announced results from a Phase II clinical trial of GSK1838262/XP13512 (gabapentin enacarbil) for neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults. GSK1838262 did not demonstrate a statistically significant improvement on the primary endpoint when compared to placebo, based on the change from baseline to end of treatment on the Pain Intensity-Numerical Rating Scale (PI-NRS). The pregabalin active control arm also did not differentiate from placebo on this same endpoint. The failure of the study to demonstrate a statistically significant benefit on the primary endpoint may be a consequence of the unexpectedly high placebo response rate observed in the study.
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