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 co-primary endpoints:
- Pain relief: 58.7 percent of patients who received LEVADEX
compared with 34.5 percent for placebo (p