The 505(b)(2) filing of NDA was supported by the results from a Phase 3 Freedom-301 clinical trial and an open-label, safety extension which was intended to investigate overall safety of Levadex over six and 12 months of exposure.
The Freedom-301 clinical trial demonstrated that the patients who took Levadex, showed improvement at two hours compared to patients on placebo.
MAP Pharma president and CEO Timothy Nelson said the FDA’s acceptance of the filing of Levadex NDA submission is an achievement in the development of Levadex.