(RxWiki News) MAP Pharmaceuticals will meet with U.S. Food and Drug Administration officials to clarify issues of concern after the agency failed to approve its investigational migraine inhaler just days ago.
FDA officials did not ask for additional studies or voice safety concerns; rather the agency was concerned with the manufacturing process of Levadex, an orally inhaled drug designed to treat acute migraine attacks in adults.
It is comprised of an inhaled form of dihydroergotamine, a medication that is usually injected to treat migraines.
"Avoid triggers that may set off your migraines."
California-based MAP reported that the FDA's complete response letter asked the company to "address issues relating to chemistry, manufacturing and controls, and observations from a recent facility inspection of a third party manufacturer."
The letter also indicated FDA officials had been unable to finish a complete review of inhaler usability information requested late in the review cycle. MAP has since scheduled a second quarter meeting with FDA officials to address issues raised in the letter.
"We are pleased that the FDA has scheduled a meeting with us to discuss the issues contained in the Complete Response letter for Levadex," said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals. "We continue to work closely together with our partner, Allergan, as we seek to resolve the issues in the complete response letter as quickly as possible."
The company had previously said it was pleased with FDA-provided revisions to product labeling and packaging, including correct trade name use.
"MAP is committed to making this important new therapy available to people who experience migraine. We will continue to work closely with the FDA to finalize our product labeling and to address the issues raised in the complete response letter as quickly as possible," Nelson said.