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MAP Pharmaceuticals Reports 2009 Fourth Quarter and Year End Financial Results
Date:3/2/2010

2009 and 2010 Year-to-Date Accomplishments and Upcoming Milestones

LEVADEX™ (formerly known as MAP0004)

  • Met all four primary endpoints in the efficacy portion of FREEDOM-301, the first Phase 3 clinical trial of LEVADEX for the potential acute treatment of migraine.  Additional endpoints showed that LEVADEX provided rapid and sustained pain relief for up to 48 hours.
  • Completed a planned six month interim safety review of the open-label, long-term safety extension of FREEDOM-301, with no drug-related serious adverse events reported.  The trial is continuing as planned.
  • Received notification from the U.S. Food and Drug Administration that a second pivotal efficacy study is not required for the LEVADEX new drug application (NDA) submission.   The remaining clinical trials needed for NDA submission include the ongoing open-label, long-term safety extension trial, a pharmacokinetics (PK) trial and a pharmacodynamics (PD) trial. The company anticipates that patients in these trials will complete treatment in 2010.
  • Initiated the PK trial in smokers and non-smokers.
  • Anticipate initiating the PD trial in the first half of 2010.
  • Presented additional analysis of FREEDOM-301 at the 14th Congress of the International Headache Society showing the potential of LEVADEX to effectively treat acute migraine as well as a broad spectr
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SOURCE MAP Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
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