MAP Pharmaceuticals announced completion of a Phase 3 trial of Levadex (dihydroergotamine (DHE)), for the acute treatment of migraine. The 12 month open-label, safety extension of the FREEDOM-301 trial was designed to evaluate overall safety of Levadex over 6 and 12 months of exposure. In total, more than 475 patients completed six months treatment and more than 250 patients completed 12 months treatment. In this trial no drug-related serious adverse events were reported. MAP has now completed the final trial necessary to support a New Drug Application (NDA) for LEVADEX and plans to submit an NDA in the first half of 2011.
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.