Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Pozen migraine combo to get committee review

Executive Summary

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)...

You may also be interested in...

Pozen MT-100 committee review postponed

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...

Pozen Migraine Combo “Not Approvable”; Imitrex Combo Could Be Affected

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

ESMO: Evidence Piles Up For AZ’s Tagrisso With ADAURA CNS Data

A new analysis of the ADAURA study shows that Tagrisso’s disease-free survival benefits in early stage EGFRm NSCLC are replicated for brain metastases, a common complication with a poor prognosis. Filings and OS data await.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts