MAP Pharmaceuticals to Resubmit Application for Migraine Treatment This Year

   By Victoria Stilwell 
 

MAP Pharmaceuticals Inc. (MAPP) said it plans to resubmit its new drug application for acute migraine treatment Levadex by the late third quarter or early fourth quarter after meeting with the U.S. Food and Drug Administration.

The biopharmaceutical company said it doesn't believe new studies are needed for the inhalable drug, which delivers a common migraine treatment in an aerosol format. Map said it believes the problems cited by the FDA--which involve manufacturing, chemistry and control issues found in an inspection of the drug-maker's third party manufacturer--have been resolved or will be addressed alongside the resubmission.

The FDA sent MAP a response letter in March outlining the issues.

"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," said Timothy S. Nelson, MAP's president and chief executive.

The FDA also requested MAP provide information on patient experience related to inhaler usability from existing clinical data, which the company said it has.

Investors have been awaiting the agency's decision on the usability of Map's inhalable drug, and Allergan Inc. (AGN) has a deal with MAP to jointly promote Levadex.

Shares of MAP closed Friday at $13.76 and were inactive in premarket trade. The stock is down almost 12% in the last 12 months.

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