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MAP Pharmaceuticals Announces FDA Acceptance for Filing of NDA for LEVADEX®
Date:8/2/2011

impact of CYP3A4 inhibition on LEVADEX pharmacokinetics. There were no drug related serious adverse events reported in any LEVADEX trial.  

About LEVADEX®

LEVADEX is an investigational drug for the acute treatment of migraine in adults, for which the Company has submitted a New Drug Application to the U.S. Food and Drug Administration. In the clinical trial, patients administered LEVADEX themselves using the proprietary TEMPO® inhaler. LEVADEX contains a novel formulation of dihydroergotamine (DHE).  LEVADEX was evaluated in the efficacy portion of FREEDOM-301, MAP Pharmaceuticals' Phase 3 pivotal trial, which included 395 patients in the LEVADEX arm and 397 patients in the placebo arm.  In the Phase 3 trial, patients taking LEVADEX 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<0.0001);
  • Phonophobia free: 52.9 percent of patients who received LEVADEX compared with 33.8 percent for placebo (p<0.0001);
  • Photophobia free: 46.6 percent of patients who received LEVADEX compared with 27.2 percent for placebo (p<0.0001); and
  • Nausea free: 67.1 percent of patients who received LEVADEX compared with 58.7 percent for placebo (p=0.02).

The most common adverse event reported in the trial was medication aftertaste at six percent versus two percent for placebo.  The next most common adverse event was nausea at five percent compared with two percent for placebo.  There were no decreases in lung function, as measured by spirometry, between the active and placebo groups. 

About Migraine

Migraine is estimated to occur in 18% of women and 6% of men in the United States.  Over 30 million people are impacted by the often debi
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SOURCE MAP Pharmaceuticals, Inc.
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