MAP Pharmaceuticals, Inc., a biopharmaceutical company focused on developing and commercializing new therapies to address undermet patient needs in neurology, has 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 has 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 time frame," 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.

The CMC issues are focused on commercial product specifications and justification of process controls to reflect the product specifications. The Company believes it has all data necessary to respond and confirmed at the FDA meeting its approach to address these issues. The FDA also agreed with the company's proposal to include recently completed 24 month stability data on Levadex in the resubmission.

The FDA provided clarity on the steps necessary for the company's third party manufacturer to address observations related to the implementation and documentation of manufacturing process controls cited during a facility inspection. The company is working closely with its third party manufacturer.  The third party manufacturer provided responses to the observations to the FDA, and the company believes the observations cited by the FDA either have been resolved or will be addressed in conjunction with the resubmission.

With respect to inhaler usability information, the FDA has requested that the company provide information on patient experience related to inhaler usability from the existing clinical data set to augment the information previously provided. The company believes it has the data necessary to provide this additional information.