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news.Map Pharmaceuticals has completed patient enrollment in the efficacy portion of its initial Phase III clinical trial evaluating MAP0004, the company's novel, orally inhaled product candidate for the acute treatment of migraine.
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The Phase III multi-center, randomized, double-blind, placebo-controlled trial in approximately 850 migraine sufferers is evaluating the safety and efficacy of MAP0004 as a potential acute treatment for migraine. The primary efficacy endpoints are pain relief and freedom from nausea, photophobia and phonophobia as measured at two hours after dosing.
The study is also evaluating earliest onset of pain relief, pain relief at 10 minutes, and sustained pain relief and freedom at 24 and 48 hours. Patients enrolled in the trial are being evaluated for the treatment of a single migraine and may continue in a long-term safety arm of the trial, enrollment in which is ongoing.
Timothy Nelson, president and CEO of Map Pharmaceuticals, said: In our Phase II clinical trial, MAP0004 demonstrated the potential to be both fast acting and long-lasting, providing pain relief in as fast as ten minutes with relief lasting for 24 and 48 hours, so we believe that MAP0004 has the potential to be a first-line therapy for migraine patients. We look forward to announcing clinical data from the efficacy portion of the trial in the first half of 2009.