MAP Pharmaceuticals, Inc. (MAPP) provided an update on LEVADEX®, the Company's investigational orally inhaled drug for the potential acute treatment of migraine in adults.
The company submitted a request to the U.S. Food and Drug Administration (FDA) for a meeting to discuss the Complete Response letter received on March 26, 2012. The company announced that the FDA has scheduled a meeting with the Company, to occur in the second quarter.
On March 26, 2012, MAP Pharmaceuticals announced that its orally inhaled investigational migraine drug, LEVADEX, has been rejected by the Food and Drug Administration.
In the letter, the FDA had requested MAP Pharma to address issues relating to chemistry, manufacturing and controls and observations from a recent facility inspection of a third party manufacturer. The regulatory agency also indicated that it had not been able to complete review of inhaler usability information requested late in the review cycle by the FDA.
On April 3, 2012, the United States Patent and Trademark Office (USPTO) issued to the Company U.S. Patent No. 8,148,377, titled "Method of Therapeutic Administration of dihydroergotamine or DHE to Enable Rapid Relief of Migraine While Minimizing Side Effect Profile." This new patent, which expires in 2028, is the third in a series of patents issued to the Company relating to the pharmacokinetics of LEVADEX.
For comments and feedback: editorial@rttnews.com