MAP Pharmaceuticals reports positive results from LEVADEX QT trial for migraine

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today reported successful results from a thorough QT trial of its investigational LEVADEX™ orally inhaled migraine therapy.  The trial evaluated the potential of a supra-therapeutic dose to cause an increase in the QT interval.  Results of the trial showed that a supra-therapeutic dose of LEVADEX does not increase QTc intervals. LEVADEX is a novel orally inhaled migraine therapy that has completed Phase 3 efficacy development for the acute treatment of migraine.  

"We are pleased that these results support our previous findings of cardiac safety from our long term open label and pharmacodynamics trials," said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals. "We continue to anticipate submitting our NDA in the first half of 2011."

This trial was a randomized, double-blind, placebo-controlled, three-way, crossover trial in 54 healthy adults comparing the acute effects of a supra-therapeutic dose of LEVADEX (approximately three times the anticipated commercial dose), oral moxifloxacin (400 mg) and placebo on the cardiac QT interval as measured by electrocardiogram.  Moxifloxacin is a positive control known to increase the QT interval.  

For the supra-therapeutic dose of LEVADEX, the largest mean difference from placebo in QTc (using the individual correction method for heart rate, or QTci) was 0.08 milliseconds, and the largest one-sided 95% upper confidence bound was 2.24 milliseconds.  The threshold level of regulatory concern is when the change produced by a drug has a 95% upper confidence bound that exceeds 10 milliseconds.  The number of subjects with individual QTc intervals > 450 milliseconds and increases in QTc from baseline > 30 milliseconds were similar to placebo.  Moxifloxacin, the positive control, produced QT prolongation consistent with previous thorough QT trials.