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www.fdanews.com/articles/75378-pozen-stops-migraine-drug-treatment-amid-safety-concerns

POZEN STOPS MIGRAINE DRUG TREATMENT AMID SAFETY CONCERNS

August 15, 2005

Drugmaker Pozen pulled the plug on its experimental migraine treatment MT 100 one day after an FDA advisory committee rejected the product based on its safety risks.

The company's recent decision follows a unanimous vote by the FDA's Peripheral and Central Nervous System Drugs Advisory Committee that concluded the benefits of MT 100 do not outweigh its risks, particularly those of tardive dsykinesia (TD), a movement disorder that affects the face, mouth, tongue and extremities. The FDA advisory committee also had recommended further study. MT 100 is a combination product composed of naproxen sodium and metoclopramide HCl in a single tablet. The drug had a proposed indication of acute treatment of migraine headache.

In May 2004, the FDA rejected MT 100 based in part on the potential risks of TD linked to the use of metoclopramide. At the advisory committee meeting, Pozen said it believed TD associated with chronic daily use of metoclopramide is a relatively rare adverse event. Metoclopramide is approved for use to treat the symptoms of a certain type of stomach problem called diabetic gastroparesis.