MAP0004 Phase 3 Program
MAP Pharmaceuticals expects to complete enrollment in its initial Phase 3 clinical trial for the acute treatment of migraine by the end of January 2009. The Phase 3 multi-center, randomized, double-blind, placebo controlled trial in approximately 850 migraine sufferers is evaluating MAP0004 as a potential acute treatment for migraine. Patients enrolled in the trial will be evaluated for the treatment of a single migraine and will continue to be followed in a long-term safety trial. MAP Pharmaceuticals is conducting this first Phase 3 trial and the long-term safety trial pursuant to a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration.
MAP0004 is a novel, orally inhaled migraine medication in development which has a multi-targeted mechanism of action, utilizes the company's proprietary TEMPO(R) inhaler and is designed to optimize the key characteristics of dihydroergotamine, an active ingredient which has been used to effectively and safely treat migraine for over 60 years. MAP0004 has the potential to provide a faster onset of action than currently available migraine treatments, with sustained pain relief and pain freedom, in an easy- to-use, non-invasive, at-home therapy. In a Phase 2 clinical trial, patients reported pain relief in as fast as 10 minutes with sustained relief to 48 hours. The safety data generated to date have shown MAP0004 to be well tolerated with no significant adverse events reported.
About MAP Pharmaceuticals, Inc.
MAP Pharmaceuticals is dedicated to developing and commercializing new
therapies for children and adults suffering from chronic conditions that are
not adequately treated by currently available medicines. The company has two
|SOURCE MAP Pharmaceuticals, Inc.|
Copyright©2009 PR Newswire.
All rights reserved