MAP Pharmaceuticals has announced plans to present analysis of data from the efficacy portion of the first phase 3 trial of its novel Levadex orally inhaled migraine therapy, currently in development, at the 14th Congress of the International Headache Society.
Data from the phase 3 trial show the potential of Levadex to be effective in treating acute migraine and migraine, including migraine subpopulations that are often resistant to current therapies such as triptans, migraine with moderate and severe pain, migraine with nausea and vomiting and migraine with and without aura.
Reportedly there were no drug-related serious adverse events reported in the trial. Levadex was well tolerated, with the most common adverse event reported being medication aftertaste at 6%, with 2% of patients receiving placebo also reporting medication aftertaste. The next most common adverse event was nausea at 5%, compared with 2% for placebo.
Timothy Nelson, president and chief executive officer of MAP Pharmaceuticals, said: “These sub-analyses further heighten our enthusiasm for Levadex and its potential to help the many patients who suffer from the debilitating effects of migraine, including the potential to provide benefit to a number of significant subpopulations of migraine patients who are not well served by currently available therapies. We look forward to continuing development of Levadex and initiating a confirmatory Phase 3 trial in the first quarter of 2010.”
Levadex data will be presented in a late-breaking oral platform presentation titled ‘Levadex, a novel orally inhaled treatment for acute migraine: efficacy and tolerability results of a phase 3 study’ at the 14th Congress of the International Headache Society in Philadelphia, PA.