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MAP Pharmaceuticals to Present Data on LEVADEX® at the 15th Congress of the International Headache Society
Date:6/23/2011

EX (MAP0004, Orally Inhaled DHE) in Healthy Volunteers — Results from 3 Clinical Studies: Pooled analyses assessing the clinical pharmacokinetics of LEVADEX and its primary metabolite across three recent clinical studies show consistent pharmacokinetic results and rapid absorption via the pulmonary route of administration.

Abstract #: A-345-0001-00616

Poster presentations will be available on the Publications section of MAP Pharmaceuticals' website at http://www.mappharma.com by the conclusion of the Congress.

About LEVADEX® LEVADEX is an investigational drug for migraine. The Company has submitted a New Drug Application to the U.S. Food and Drug Administration for the potential acute treatment of migraine in adults. 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 was medication aftertaste at six percent versus two percent for placebo.  The next most commo
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    SOURCE MAP Pharmaceuticals, Inc.
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