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news.GlaxoSmithKline (GSK) and XenoPort's GSK1838262/XP13512 (gabapentin enacarbil) did not demonstrate improvement compared to placebo as a prophylactic treatment for migraine headaches in Phase 2b study.
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XP13512 is a patented new chemical entity discovered by XenoPort. GSK and XenoPort said that the failure of the study may be a consequence of the unexpectedly high placebo response rate observed.
The 30-week, double-blind, placebo-controlled study randomised 526 patients to receive 1200, 1800, 2400 or 3000mg/day of GSK1838262 or placebo, administered twice daily.
Atul Pande, senior vice president of neurosciences medicines development center at GSK, said: “We are disappointed by the results of GSK1838262 in this clinical setting. Unfortunately, migraine remains an often debilitating and undertreated condition.
“According to published studies, up to 40% of migraine sufferers could benefit from preventative therapies.”
Ronald Barrett, CEO of XenoPort, said: “XenoPort is disappointed by these study results, especially the high placebo response rate, which may have impacted the ability of the trial to detect the potential benefit of GSK1838262 in patients with migraine headaches.
“We remain committed to working with our partners and regulatory authorities to make this product candidate available to patients with unmet medical needs.”