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Data from FREEDOM-301 Study for LEVADEX™ Orally Inhaled Migraine Drug Published in 'Headache'
Date:4/7/2011

o group  (p=0.0210)

Four prospectively defined secondary endpoints also were analyzed:

  • Sustained pain relief from two to 24 hours was observed in 44% of patients in the LEVADEX treatment group compared with 20% for the placebo group (p<0.0001)
  • The statistically significant time to pain relief was calculated to be 30 minutes (p=0.0266)
  • Pain relief at four hours was observed in 65% of patients in the LEVADEX treatment group compared  with 37% for the placebo group (p<0.0001)
  • The proportion of patients experiencing pain relief at 10 minutes, while not statistically significant, was 50% greater in the LEVADEX treatment group (9%) compared with the placebo group (6%) (p=0.16)  

  • LEVADEX was well tolerated, with no drug-related serious adverse events reported during the study. The most common adverse events reported were medication aftertaste (6%) and nausea (5%), both compared to 2% for placebo. Triptan sensations such as chest discomfort (1%), chest pain (0%) and paresthesias (0.5%) were rare in patients treated with LEVADEX and comparable to placebo.

    "We are pleased to have our Phase 3 data published in 'Headache.' These data are part of a comprehensive clinical program that evaluated LEVADEX in approximately 1,000 patients, treating nearly 10,000 migraines," said Donald J. Kellerman, MAP Pharmaceuticals' Senior Vice President, Clinical Development and Medical Affairs. "We look forward to submitting our NDA for LEVADEX for the acute treatment of migraine in the first half of 2011 and, if approved by the FDA, moving one step closer to our goal of providing the migraine patient population with a new treatment option."

    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,
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    SOURCE MAP Pharmaceuticals, Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

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