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MT 100 must show more benefit

August 5, 2005 1:14 AM UTC

An FDA panel rendered a vote on Thursday that means a new trial of migraine compound MT 100 from Pozen (POZN) would have to demonstrate a greater benefit than that seen in previous trials before the compound could be approved. FDA issued a not approvable letter for the combination of naproxen and metoclopramide to treat migraine in 2004.

All twelve members of the Peripheral and Central Nervous System Drugs Advisory Committee voted that another trial in non-nauseated patients that replicates the 4-6% improvement on sustained headache relief seen in previous trials would not be sufficient to outweigh the risk of tardive dyskinesia (TD). Metoclopramide, which is approved for short-term use to treat GERD after conservative treatments have failed, has been reported to cause TD, a potentially permanent movement disorder. ...