MAP Pharmaceuticals Initiates Phase 3 Clinical Trial in Patients Wit...( MOUNTAIN VIEW Calif. July 14 /- M...),Health

MOUNTAIN VIEW, Calif., July 14 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced it has initiated its Phase 3 clinical program to evaluate MAP0004 as a potential treatment for migraine.

MAP0004 is orally inhaled and self-administered at home using MAP Pharmaceuticals' proprietary Tempo(R) inhaler. In the company's prior Phase 2 efficacy study, MAP0004 provided pain relief in as fast as 10 minutes, with relief sustained through at least 24 hours. The study also demonstrated efficacy trends in treating nausea, photophobia and phonophobia, the other key measurements in treating migraine.

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 freedom from 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 also 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. In our Phase 2 trials, MAP0004 was well tolerated with no effect on pulmonary function, including in asthmatic subjects."

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