MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced that the Company completed an End-of-Review meeting with the United States Food and Drug Administration (FDA) for its New Drug Application (NDA) for LEVADEX® (dihydroergotamine) inhalation aerosol. MAP Pharmaceuticals requested the End-of-Review meeting following receipt of a Complete Response letter (CRL) on March 26, 2012. The Company is seeking approval of LEVADEX for the acute treatment of migraine in adults.
"Based on our meeting with the FDA, we believe that we have clarity on what is needed to address the issues in the Complete Response letter, and we are encouraged by the FDA's collaborative dialogue in providing guidance that will help us move forward with our resubmission process. We plan to resubmit to the FDA in the late third quarter/early fourth quarter 2012 timeframe," said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals. "We believe LEVADEX has the potential to be an important new therapy for people who experience migraine and look forward to being able to provide it to patients whose needs are not being met by currently available treatments."
Based on the meeting, the Company believes that no new studies need to be conducted for inclusion in the resubmission. The FDA will determine the type of resubmission (Class 1 or Class 2) and the resulting review timeline after the resubmission has been accepted for filing.
In the CRL, the FDA requested that the Company address issues relating to chemistry, manufacturing and controls (CMC) and observations from a facility inspection of a third party manufacturer. The FDA also indicated that it had not been able to complete review of inhaler usability information requested late in the review cycle by the FDA.