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The primary efficacy endpoints will be pain relief, and diminished nausea, photophobia, and phonophobia.
MAP Pharmaceuticals, Inc. initiated its Phase 3 clinical program to evaluate MAP0004 as a potential migraine treatment. MAP0004, which consists of therapeutic agent dihydroergotamine (DHE), is orally inhaled and self-administered at home using MAP Pharmaceuticals' Tempo inhaler.
This randomized, double-blind, placebo-controlled Phase 3 trial is designed to evaluate the efficacy and safety of MAP0004 in treating acute migraine. The primary efficacy endpoints will be pain relief, and diminished nausea, photophobia, and phonophobia as measured at two hours after dosing. MAP will also evaluate earliest onset of pain relief and sustained relief to 24 and 48 hours. The multi-center efficacy trial will include approximately 850 patients, who will be followed for 12 months in an open-label study to confirm long-term safety.
"We believe that MAP0004 has the potential to be a first-line therapy for migraine patients," said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals. "Based on our initial clinical studies, we believe that MAP0004 offers an alternative to triptans that may provide patients with the benefits of rapid onset and long-lasting pain relief, in an easy-to-use, non-invasive, at-home therapy."
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