MAP Pharmaceuticals' NDA for Levadex, an orally inhaled migraine drug for the potential acute treatment of migraine in adults, has been accepted for filing by the FDA. The application has a goal date of March 26, 2012 under PDUFA. FDA's acceptance of the filing has triggered a $20 million milestone payment from development partner Allergan to MAP.
"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. "This takes us another step forward in our effort to provide the underserved migraine patient population with a potential new treatment option."
MAP's 505(b)(2) NDA submission for Levadex includes efficacy and safety data from the Phase III 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. Nearly 10,000 migraines were treated.
The NDA is also supported by data from a trial evaluating the PK and safety of Levadex in smokers and non-smokers, a 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 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 of the trials.