XenoPort, Glaxo Migrane Drug Fails To Outperform Placebo

7th Jul 2010 14:05

DOW JONES NEWSWIRES GlaxoSmithKline PLC (GSK, GSK.LN) and XenoPort Inc. (XNPT) said a drug didn't produce statistically significant improvement in treating migraine headaches than a placebo in a midstage trial. The 30-week study included 526 patients at four dosing levels twice a day, and the study's failure could be due to an unexpectedly high placebo response, the companies said. There were eight adverse responses in the study, including one not related to the study and another whose relationship was not established. The drug is designed to provide sustained exposure of gabapentin by taking advantage of transport mechanisms in the gastrointestinal tract. A new-drug application for gabapentin enacarbil to treat for moderate-to-severe primary restless-legs syndrome is under review by the U.S. Food and Drug Administration. But the agency said in February it wouldn't approve it at that time amid a preclinical finding of pancreatic acinar cell tumors in rats. A month later, XenoPort in March slashed its work force by nearly half to focus on advancing its clinical-stage product candidates and cut annual expenses. XenoPort shares closed Tuesday at $8.87 and was trading at $6.15, down 30.7%, premarket. The stock is down 52% this year. -By Tess Stynes, Dow Jones Newswires; 212-416-2481; [email protected] (END) Dow Jones Newswires July 07, 2010 09:05 ET (13:05 GMT)