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Pozen MT-100 committee review postponed

Executive Summary

May review of Pozen's MT-100 migraine treatment by FDA's Peripheral & Central Nervous System Drugs Advisory Committee is postponed due to "FDA scheduling conflicts." The meeting was to address potential risk of tardive dyskinesia with MT-100, a combination of metoclopromide and naproxen (1"The Pink Sheet" Jan. 3, 2005, In Brief). The company is discussing future meeting dates with FDA; the only tentative date scheduled for the committee is Aug. 4...

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Pozen MT 100 review

FDA's Peripheral & Central Nervous System Drugs Advisory Committee will meet Aug. 4 to discuss tardive dyskinesia risks with Pozen's MT 100 (metoclopromide/naproxen) for treatment of migraine. A tentative meeting on the issue set for May was postponed by FDA due to what Pozen said were scheduling conflicts (1"The Pink Sheet" May 2, 2005, In Brief). The meeting will be held at the CDER advisory committee conference room at 5630 Fishers Lane in Rockville, Md. beginning at 8 a.m. [Editor's Note: To 2watch a webcastor order a video/DVD of this meeting, visit]...

Pozen migraine combo to get committee review

Pozen's naproxen/metaclopramide migraine combination is slated to be reviewed by FDA's Peripheral & Central Nervous System Drugs Advisory Committee May 4, firm says. Committee will place "particular emphasis" on potential risk of metaclopramide-induced tardive dyskinesia, Pozen says. Decision to present drug to committee came after "series of meetings" with FDA; MT-100 was deemed "not approvable" in May 2004 due to both efficacy and safety concerns (1"The Pink Sheet" June 7, 2004, p. 37)...

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