Washington Editor

WASHINGTON - An FDA panel is gathering today to discuss a licensing application for MT 100, a migraine drug developed by Pozen Inc.

The new drug application for the oral product, a combination of naproxen sodium and metoclopramide, generated a not-approvable letter last year because it did not clearly meet certain criteria and failed to show superiority over naproxen for sustained pain relief. Also in the FDA rejection, the agency raised safety issues related to risks of tardive dyskinesia, a side effect that causes involuntary movement, usually of the face and tongue. (See BioWorld Today, June 2, 2004.)

The company and the FDA said the meeting would have a particular emphasis on MT 100's potential risk of tardive dyskinesia. Today's review will be conducted by the FDA's Peripheral and Central Nervous System Drugs Advisory Committee.

On the day the not-approvable letter was announced last year, shares in the Chapel Hill, N.C.-based company fell 37.2 percent. Pozen's shares (NASDAQ:POZN) dropped 15 cents on Wednesday, to close at $8.40.

MT 100's new drug application was filed two years ago, after which the company added rat carcinogenicity data to the submission. Clinical studies enrolled more than 7,700 patients. The rodent findings provided no evidence that maximum tolerated doses of metoclopramide and naproxen produced any statistically significant differences in findings from those seen with metoclopramide alone. On its own, metoclopramide is used to relieve nausea and enhance gastric emptying, while naproxen is a non-steroidal anti-inflammatory drug for pain. (See BioWorld Today, Aug. 1, 2003, and Jan. 29, 2004.)

In the past, an FDA application for another Pozen drug for migraines, MT 300, resulted in a not-approvable letter. More recently, the company's migraine drug developments have been a bit more upbeat relative to Trexima (formerly MT 400), a product partnered with London-based GlaxoSmithKline plc. Earlier this year, Pozen reported data showing that the triptan drug met all regulatory endpoints in the second of two pivotal trials. (See BioWorld Today, April 22, 2005.)