ARTICLE | Company News

Pozen's MT 100 not approvable

June 1, 2004 7:00 AM UTC

POZN was down $3.69 (37%) to $6.23 on 8.9 million shares on Tuesday after it received a not-approvable letter from FDA for its MT 100 to treat acute migraine. The agency's letter said that MT 100, a combination of naproxen and metoclopramide, did not show superiority over naproxen on the primary endpoint of sustained pain relief in two trials. POZN said there was a "difference in understanding between Pozen and the Agency as to the appropriate statistical analysis" of the primary endpoint.

FDA's letter also cited potential risks of tardive dyskinesia and carcinogenicity. POZN said it would request a meeting with FDA. MT 100 is under review in Europe. In October 2003, POZN said it would respond to undisclosed comments from the U.K.'s MHRA regulatory agency regarding the MAA. ...