MAP Pharmaceuticals, a developer and commercializer of new therapies to address undermet patient needs in neurology, has filed a new drug application (NDA) for an orally inhaled migraine drug, Levadex, with the US Food and Drug Administration (FDA).
The 505(b)(2) filing of NDA was supported by the results from a Phase 3 FREEDOM-301 clinical trial which demonstrated that the patients who took Levadex, showed improvement at two hours compared to patients on placebo.
The 12 month open-label, safety extension of the Phase 3 FREEDOM-301 trial was intended to investigate the overall safety of Levadex over six and 12 months of exposure.
MAP Pharma president and CEO Timothy Nelson said their comprehensive development program evaluated Levadex in approximately 1,000 patients for up to one year, treating nearly 10,000 migraines.
"If approved by the FDA, Levadex could potentially provide a new treatment option for migraine sufferers, including the millions of patients whose migraines are not well treated today," Nelson said.