Peripheral and Central Nervous System Drugs

 

Advisory Committee Meeting

 

4 August 2005

 

 

POZEN Inc.

1414 Raleigh Road

Suite 400

Chapel Hill, NC 27157

USA

 

 

 

TABLE OF CONTENTS

 

 

Background Information

 

Appendix 1           Reglan® Package Insert

 

Appendix 2           HRA Document -- Postmarketing AEs with metoclopramide

 

Appendix 3           Information on Use of Metoclopramide for Treatment of Migraine in UK obtained from CompuFile Limited

 

Appendix 4           Consensus Statement by Clinician Advisory Pane

 

Appendix 5           Sustained Pain Response – Statistical Analyses of this Endpoint in Study 301 and Study 304

 

Appendix 6           Independent Analyses by Drs. Lipton and Kolodner

 

References