A goal date of March 26, 2012 has been set for the NDA submitted to the FDA for MAP Pharmaceuticals’ Levadex inhaled dihydroergotamine (DHE) for the treatment of migraine in adults. The acceptance triggered a $20 million milestone payment to MAP from Allergan, which has partnered with MAP on development of the product in the US. Ownership of the NDA will be retained by MAP.
MAP President and CEO Timothy S. Nelson said, “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. This takes us another step forward in our effort to provide the underserved migraine patient population with a potential new treatment option.”
The novel dry powder formulation of DHE in Levadex is delivered using the Tempo DPI. Allergan and MAP have previously announced that they will develop the inhaler for additional indications, including adolescent migraine, if the FDA approves the product for the treatment of adult migraine.
Read the MAP press release.
