May 26, 2009
Phase 3 study of Levadex for the treatment of migrainesMAP Pharmaceuticals announced that the efficacy portion of its first Phase 3 trial evaluating its novel migraine therapy, Levadex (dihydroergotamine (DHE)), met all four primary endpoints. This study, named FREEDOM-301, is a multi-center, randomized, double-blind, placebo-controlled trial of 792 patients, 18-65 years of age, designed to evaluate the safety and efficacy of Levadex as a potential treatment for acute migraine. Primary efficacy measures include pain relief, and being phonophobia, photophobia and nausea free at two hours after dosing. Additional endpoints showed that LEVADEX provided rapid and sustained pain relief for up to 48 hours after dosing.
Levadex is an orally inhaled migraine therapy designed to provide both fast onset of action and sustained pain relief and other migraine symptom relief in an easy-to-use and non-invasive at-home therapy.
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