MAP Pharmaceuticals, Inc. 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 per cent upper confidence bound was 2.24 milliseconds. The threshold level of regulatory concern is when the change produced by a drug has a 95 per cent 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.
Levadex orally inhaled migraine therapy is a novel migraine therapy in phase 3 development. Patients administer Levadex themselves using the company's proprietary Tempo inhaler. Levadex has been designed to be differentiated from existing migraine treatments. It is a novel formulation of dihydroergotamine (DHE), a drug used intravenously in clinical settings to effectively and safely treat migraines. Based on clinical results, the company believes that Levadex has the potential to provide both fast onset of action, sustained pain relief and other migraine symptom relief in an easy-to-use and non-invasive at-home therapy.
Levadex is designed to incorporate the multiple beneficial mechanisms of action that allow DHE to block initiation of migraine, limit pain, reduce inflammation and stop a migraine at any point in the migraine cycle. Based on research to date, including the efficacy portion of the FREEDOM-301 trial, the company believes the unique pharmacokinetic profile of Levadex has the potential to effectively treat migraines, while minimizing the side effects commonly seen with DHE and other currently available medicines.
MAP Pharmaceuticals is an emerging biopharmaceutical company focused on developing and commercializing new therapies to address undermet patient needs in neurology.