Peripheral and Central Nervous System Drugs Advisory Committee


August 4, 2005




Sponsor Presentations

Pozen Incorporated


            Introduction and Summary                                Marshall E. Reese, Ph.D.

Executive Vice President, Product Development

Pozen Incorporated


Overview of Tardive Dyskinesia                        A.H.V. (Tony) Schapira, M.D.

Professor of Neurology,

Royal Free Hospital School of Medicine

London, United Kingdom


Review of MT100 Efficacy                               William James Alexander, M.D., M.P.H., F.A.C.P

                                                                                    Senior Vice President, Clinical Development

                                                                                    Chief Medical Officer

                                                                                    Pozen Incorporated


            Potential Role of MT100 in Migraine                 David B. Matchar, M.D., F.A.C.P.

Therapy: Balancing Benefits and Risks               Director, Duke Center for Clinical Health Policy


                                                                        Professor of Medicine

Duke University School of Medicine


Clinical Considerations on                                 Stephen D. Silberstein, M.D.

Migraine Treatment                                           Director, Jefferson Headache Center

Thomas Jefferson University Hospital

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FDA Presentations

FDA Risk/Benefit Considerations                      Eric Bastings, M.D.

Clinical Team Leader, DNP, FDA

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Overview of Tardive Dyskinesia                        Hyder A. Jinnah, M.D., Ph.D.

The Johns Hopkins Hospital

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Post-marketing Review of Movement                Mary Ross Southworth, Pharm.D.

Disorders and Neuroleptic Malignant                Safety Evaluator, Division of Drug Risk Syndrome

Associated with Metoclopramide                      Evaluation, Office of Drug Safety, FDA

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            Questions from the Committee to the Sponsor and FDA

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