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MAP Pharmaceuticals Phase 3 Trial of LEVADEX(TM) Migraine Product Candidate Meets All Four Primary Endpoints
Date:5/26/2009

- Both Rapid and Sustained Pain Relief for up to 48 Hours -

- Conference Call to be Held Today at 8:30 a.m. ET -

MOUNTAIN VIEW, Calif., May 26 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) announced today that the efficacy portion of its first Phase 3 clinical trial evaluating its novel LEVADEX(TM) orally inhaled migraine therapy met all four primary endpoints. Additional endpoints showed that LEVADEX provided rapid and sustained pain relief for up to 48 hours after dosing.

Patients taking LEVADEX therapy (formerly referred to as MAP0004) had statistically significant improvement at two hours compared to patients on placebo for each of the 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).

A total of 792 patients were included in the primary data analysis as specified in the protocol of the FREEDOM-301 study, which was conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA). The patient population studied had more severe migraine pain than expected, with 46 percent reporting severe pain and 54 percent reporting moderate pain prior to administration of the study drug.

Results from additional pre-defined analyses include:

  • LEVA
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SOURCE MAP Pharmaceuticals, Inc.
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