NDA Submitted for Levadex for Migraine
MAP Pharmaceuticals announced that it has submitted a NDA to the FDA for Levadex (dihydroergotamine) for the potential acute treatment of migraine in adults. The NDA submission is based on a comprehensive development program for Levadex, and includes efficacy and safety data from the Phase 3 FREEDOM-301 study. Patients taking Levadex in this pivotal trial had statistically significant improvement at 2 hours compared to patients on placebo for all four co-primary endpoints.
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.
For more information call (650) 386-3100 or visit www.mappharma.com.