MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) announced today it will present new analyses from the FREEDOM-301 Phase 3 clinical trial in a late breaker session at the 52nd Annual Scientific Meeting of the American Headache Society (AHS) in Los Angeles, California on Friday, June 25 from 3:30 to 4:00 pm PT. The presentation will show that the Company's investigational LEVADEX™ orally inhaled migraine therapy was effective irrespective of when it was administered during a migraine cycle. Separately, the Company also will present efficacy and safety analyses of a subgroup of migraine patients with concomitant asthma.
The post hoc analysis, to be presented by Stewart Tepper, M.D., Director of Research for the Center for Headache and Pain at the Cleveland Clinic, showed LEVADEX was effective in treating a migraine attack with moderate or severe pain when administered as soon as the initial migraine onset and as late as eight hours after the start of the migraine. 771 patients treated a moderate to severe qualifying migraine, recorded efficacy and time to treatment data, and were included in this post hoc analysis. Two hour pain relief and two hour pain free rates were compared between active and placebo in those who treated their migraine within one hour, between one and four hours, between four and eight hours and greater than eight hours after the onset of the migraine.
"Several published studies have shown that the efficacy of triptans is reduced significantly when treatment is delayed. However, many patients may be unable or unwilling to treat migraine early in an attack," said Dr. Tepper. "Patients are looking to remedy this with a therapy that works when administered at any time during the migraine cycle."
A second post hoc analysis of the FREEDOM-301 trial data, to be presented in a poster session at AHS on Friday, June 25 from 12:30 - 1:30 pm PT, showed LEVADEX was both effective and well tolerated in migraine patients with asthma, a disorder commonly concomitant with migraine. Of 792 total patients who treated a migraine during the efficacy portion of the study, 80 were asthmatics and were included in the subanalysis. The efficacy results were consistent with the results of the entire study. In addition, the inhaled route of administration presented no significant differences in safety for migraine subjects with or without concomitant asthma.
A study evaluating the long term safety of LEVADEX for up to one year in migraine patients, including those with and without asthma, is ongoing.
As previously reported, LEVADEX met all four co-primary endpoints, as well as a number of secondary endpoints, and was well tolerated, with no drug related serious adverse events reported, in the efficacy portion of the FREEDOM-301 trial.
MAP Pharmaceuticals, Inc.