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MAP Pharmaceuticals to Present Data on LEVADEX™ at the 63rd Annual Meeting of the American Academy of Neurology
Date:2/28/2011

lopment.  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 therapy 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 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 Common symptoms of migraine include recurrent headaches, nausea, vomiting, photophobia (sensitivity to light) and phonophobia (sensitivity to sound).  According to the National Headache Foundation, most migraines last between four and 24 hours, but some last as long as three days.  On average, migraine sufferers experience 1.5 migraine attacks monthly, although 25 percent of them experience one or more attacks weekly.  The economic burden of migraine remains substantial despite existing treatments, with the direct and indirect costs of migr
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    SOURCE MAP Pharmaceuticals, Inc.
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