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.
Write to Victoria Stilwell at Victoria.Stilwell@dowjones.com