MOUNTAIN VIEW, Calif. (AP) – MAP Pharmaceuticals Inc. said it will again file for marketing approval of its inhaled migraine treatment Levadex late in the third quarter or early in the fourth quarter of 2012.
The company said it has finished a new round of meetings with the Food and Drug Administration, which declined to approve Levadex in March. MAP said it believes it has clinical data that will address all of the FDA’s concerns about the chemistry, manufacturing and controls of Levadex and its observations at a third-party manufacturing facility, as well as more information about the inhaler that delivers the drug.
MAP said the FDA had not had time to complete a review of the inhaler.
It is not clear how long the FDA will take to review the new submission. Similar reviews generally take either two or six months. MAP said it does not expect to have to run additional clinical trials of Levadex.
MAP does not have any products on the market, and Levadex is its most advanced experimental drug. Levadex is version of the migraine drug dihydroergotamine, and it is designed to be self-administered through the inhaler. MAP is developing the drug through a partnership with Allergan Inc., and the companies will share profits if it is approved. They are also studying Levadex as a treatment for pediatric migraines and cluster headaches.
Date: June 25, 2012
Source: Associated Press