MAP Pharmaceuticals, Inc. announced that its New Drug Application (NDA) for Levadex orally inhaled migraine drug for the potential acute treatment of migraine in adults has been accepted for filing by the US Food and Drug Administration (FDA), with a goal date of March 26, 2012 under the Prescription Drug User Fee Act (PDUFA). In accordance with the company's collaboration agreement with Allergan, Inc., the FDA's acceptance for filing of the NDA triggers a milestone payment to MAP Pharmaceuticals of $20 million.

"We are very pleased with the FDA's acceptance of the filing of our Levadex NDA submission as it is a significant achievement in the development of Levadex," said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals. "This takes us another step forward in our effort to provide the underserved migraine patient population with a potential new treatment option."

The company's 505(b)(2) NDA submission for Levadex includes efficacy and safety data from the pivotal phase 3 FREEDOM-301 clinical trial and the open-label, safety extension which was designed to evaluate overall safety of Levadex over six and 12 months of exposure. In total, more than 475 patients completed six months of treatment and more than 250 patients completed 12 months of treatment. In total, nearly 10,000 migraines were treated.  The NDA is also supported by data from a pharmacokinetics (PK) trial evaluating the PK and safety of Levadex in s Levadex non-smokers, a pharmacodynamics (PD) trial evaluating the acute effects of Levadex on pulmonary artery pressure, a thorough QT trial comparing the acute effects of a supra-therapeutic dose of Levadex on the cardiac QT interval as measured by electrocardiogram, a safety trial in adult asthmatics and a drug interaction study assessing the impact of CYP3A4 inhibition on Levadex pharmacokinetics. There were no drug related serious adverse events reported in any Levadex trial.  

Levadex is an investigational drug for the acute treatment of migraine in adults, for which the company has submitted a New Drug Application to the US Food and Drug Administration. In the clinical trial, patients administered Levadex themselves using the proprietary TEMPO inhaler. Levadex contains a novel formulation of dihydroergotamine (DHE).  Levadex was evaluated in the efficacy portion of FREEDOM-301, MAP Pharmaceuticals' phase 3 pivotal trial, which included 395 patients in the Levadex arm and 397 patients in the placebo arm.  In the phase 3 trial, patients taking Levadex had statistically significant improvement at two hours compared to patients on placebo for all four co-primary endpoints: Pain relief: 58.7 percent of patients who received Levadex compared with 34.5 percent for placebo (p<0.0001); Phonophobia free: 52.9 percent of patients who received Levadex compared with 33.8 percent for placebo (p<0.0001); Photophobia free: 46.6 percent of patients who received Levadex compared with 27.2 percent for placebo (p<0.0001); and Nausea free: 67.1 percent of patients who received Levadex compared with 58.7 percent for placebo (p=0.02).

MAP Pharmaceuticals is an emerging biopharmaceutical company focused on developing and commercializing new therapies to address undermet patient needs in neurology.