MT 100

Treatment for Migraine

POZEN Provides Results of FDA Advisory Committee Meeting on MT 100 (Naproxen Sodium and Metoclopramide Hydrochloride)

CHAPEL HILL, N.C., August 5, 2005 -- POZEN Inc. (NASDAQ: POZN) announced that the U.S. Food and Drug Administration's (FDA) Peripheral and Central Nervous Systems Drugs Advisory Committee met yesterday to specifically address the risk of tardive dyskinesia, an involuntary neurological movement disorder associated with the use of metoclopramide hydrochloride, one of the components of MT 100. The Advisory Committee voted that the potential, but unquantified, risk for tardive dyskinesia would outweigh the benefits, as defined by the FDA, of metoclopramide hydrochloride in combination with naproxen sodium. The company received a "not approvable" letter from the FDA in May 2004.

"Based on a thoughtful review of the outcome of yesterday's meeting, we have decided to discontinue further development of MT 100 in the U.S.," said Dr. John R. Plachetka, POZEN's chairman, president and chief executive officer. "Part of the reason for this is that we expect to file the Trexima NDA shortly, and Trexima has already demonstrated greater efficacy without the metoclopramide risk associated with MT 100."

POZEN has licensed Trexima to GlaxoSmithKline for commercialization in the U.S. In addition to Trexima, POZEN's pipeline of product candidates include PN 100, PN 200, and PA 100, along with lornoxicam parenteral and oral opportunities.

Source: POZEN Inc.

Posted: August 2005

Related Articles

MT 100 (naproxen sodium and metoclopramide HCl) FDA Approval History

View comments

Hide
(web4)