MOUNTAIN VIEW, Calif., May 26, 2011 /PRNewswire/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced that it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for LEVADEX® orally inhaled migraine drug for the potential acute treatment of migraine in adults. According to the National Headache Foundation, approximately 30 million people in the United States suffer from migraine, a debilitating neurological disorder. Common symptoms of migraine include recurrent headaches, nausea, phonophobia (sensitivity to sound) and photophobia (sensitivity to light).
"This NDA submission marks a major corporate milestone for MAP Pharmaceuticals and brings us one step closer to our goal of providing the underserved migraine patient population with a potential new treatment option," said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals. "Our comprehensive development program evaluated LEVADEX in approximately 1,000 patients for up to one year, treating nearly 10,000 migraines. If approved by the FDA, LEVADEX could potentially provide a new treatment option for migraine sufferers, including the millions of patients whose migraines are not well treated today."
The 505(b)(2) NDA submission is based on a comprehensive development program for LEVADEX, and includes efficacy and safety data from the Phase 3 FREEDOM-301 clinical trial that has been presented at scientific conferences and was recently published in Headache: The Journal of Head and Face Pain. In the FREEDOM-301 trial, patients self-administered LEVADEX at home using the Company's proprietary TEMPO® inhaler. LEVADEX contains a novel formulation of dihydroergotamine (DHE). Patients taking LEVADEX in this pivotal trial had statistically significant improvement at two hours compared to patients on placebo for all four c
|SOURCE MAP Pharmaceuticals, Inc.|
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