Pozen Migraine Combo “Not Approvable”; Imitrex Combo Could Be Affected
Executive Summary
FDA's "not approvable" letter for Pozen's naproxen/ metoclopramide migraine combination MT-100 may prompt the company to revisit the Phase III trial design for an Imitrex combo under development with GlaxoSmithKline
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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)...
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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William Stagner will fill Pozen's newly created position of senior VP-program management & development planning. Stagner previously served as Cardinal Health senior VP & general manager. Stagner reports to recently appointed Exec VP-Product Development Marshall Reese. The additions follow FDA's "not approvable" letter for Pozen's naproxen/metoclopramide migraine combination MT-100 (1"The Pink Sheet" June 7, 2004, p. 37)...