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news.MAP Pharmaceuticals has announced the completion of phase III trial, thus achieving four primary endpoints for Levadex, an orally inhaled migraine therapy. Data for the trial showed that Levadex provided rapid and sustained pain relief for up to 48 hours after dosing.
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The trial (Freedom-301), a multi-center, randomized, double-blind, placebo-controlled Phase 3 trial designed to evaluate the safety and efficacy of Levadex as a potential treatment for acute migraine. Primary efficacy measures included pain relief, and being phonophobia, photophobia and nausea free at two hours after dosing.
A total of 792 patients were enrolled in the primary trial, which was conducted under a Special Protocol Assessment agreement with the US Food and Drug Administration (FDA).
Timothy S. Nelson, President and Chief Executive Officer of MAP Pharmaceuticals, said: we are very pleased with these results and look forward to continuing development of Levadex with the goal of bringing this differentiated therapy to the many patients who suffer from the debilitating effects of migraine. Unlike currently available migraine therapies, we believe that Levadex has the potential to address all these patient needs and to offer a significant advancement in migraine therapy for this underserved patient population.