Map Pharmaceuticals announces completion of Levadex open-label safety trial.

Map Pharmaceuticals Inc announced completion of the Levadex open-label safety trial. The company has now completed the final trial necessary to support a New Drug Application (NDA) for Levadex and plans to submit an NDA in 1H 2011. Levadex is a novel orally inhaled migraine therapy that has completed Phase III clinical development for the acute treatment of migraine. This clinical trial completes a comprehensive 505(b)(2) clinical development programme which evaluated the efficacy, safety, pharmacokinetics and pharmacodynamics of Levadex in about 1000 patients. The 12 month open-label, safety extension of the Phase III FREEDOM-301 trial was designed to evaluate overall safety of Levadex …