GlaxoSmithKline: No Improvement For GSK1838262/XP13512 Vs Placebo

7th Jul 2010 13:45

LONDON (Dow Jones)--Pharmaceutical firms GlaxoSmithKline PLC (GSK) and XenoPort, Inc. (XNPT) said Wednesday GSK1838262/XP13512 (gabapentin enacarbil) didn't demonstrate a statistically significant improvement compared to placebo as a prophylactic treatment for migraine headaches. MAIN FACTS: -This phase 2 billion dose-ranging study evaluated the efficacy, safety and tolerability of GSK1838262 in adults diagnosed with migraine headache (with or without aura) according to the International Headache Society criteria. -The 30-week, double-blind, placebo-controlled study randomized 526 patients to receive 1200, 1800, 2400 or 3000 mg/day of GSK1838262 or placebo, administered twice daily. -Primary efficacy endpoint was the change from baseline in the number of migraine headache days during the last four weeks of treatment prior to taper. -Failure of the study may be a consequence of the unexpectedly high placebo response rate observed. -GlaxoSmithKline shares at 1240 GMT down slightly at 1122.87 pence valuing the company at GBP57.87 billion. -By Ian Walker, Dow Jones Newswires; 44-20-7842-9296; [email protected] (END) Dow Jones Newswires July 07, 2010 08:45 ET (12:45 GMT)