Citing an unexpectedly high placebo response, XenoPort and GlaxoSmithKline reported this morning that their experimental therapy to treat numbness in diabetes patients failed a mid-stage trial.
Ronald Barrett, the CEO of XenoPort, says that a high placebo response has been seen in a variety of trials for new drugs to treat peripheral diabetic neuropathy.
"The failure of pregabalin in this study makes it difficult to draw definitive conclusions about the efficacy of GSK1838262," adds Barrett. "We are encouraged by the observation that all doses of GSK1838262 were generally well tolerated, particularly since the 3600 mg dose represents the highest dose tested in a study of this length."
And Atul Pande, senior vice president of Glaxo's Neurosciences Medicines Development Center, said that both companies would closely evaluate the response before deciding on the next step. The drug is up for FDA approval for use to treat restless leg syndrome following a successful late-stage trial.
- check out the release
- read the Dow Jones report
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