Agenda: May 10, 2002
Psychopharmacological Drugs Advisory Committee
Holiday Inn, Bethesda, Maryla nd
NDA 21-431: Acamprosate 333 mg tablets (Lipha Pharmaceuticals, Inc.)
8:00 Call to Order, Introductions
Dan Oren, M.D., Acting Chair, PDAC
Conflict of Interest Statement
Sandra Titus, Ph.D., Executive Secretary, PDAC
Welcome and Introductory Comments
Cynthia McCormick, M.D., Director, Anesthetic, Critical Care and Addiction Drug Products
8:15 Lipha Presentations
Introduction
Anita M. Goodman, M.D., Executive Vice-President and COO, Lipha
European Development Program and Current Registration Status
Sylvie Chabac, M.D., International Project Manager, MERCK/Lipha s.a.
Acamprosate: Mechanism of Action, Preclinical Effects, & Pharmacokinetic Overview
George F. Koob, Ph.D., Professor, Director Neuropharmacology, Scripps Research Institute
Efficacy Results from 3 Pivotal Clinical Trials
Karl F. Mann, M.D., Department of Addiction Medicine, University of Heidelberg, Germany
Analysis of the US Study Results
Barbara J. Mason, Ph.D., Director, Division of Substance Abuse, U of Miami School of Medicine
Closing Remarks
Anita M. Goodman, M.D
9:15 Questions from the Committee to Lipha
10:00 Break
10:30 FDA Presentations
Clinical Issues on Efficacy
Celia Winchell, M.D., Medical Team Leader, Anesthetic, Critical Care and Addiction Drug Products
Statistical Perspective of Acamprosate Experience
Sue Jane Wang, Ph.D., Statistics Leader in Alcoholism Treatment Clinical Trials, Office of Biostatistics
11:30 Questions from the Committee to FDA
12:15 Lunch
1:15 Open Public Hearing
Victor Hasselbok, Ph.D.,Vice President Research Society on Alcohol
Jonathan Chick, M.D., Co-Director Alcohol Problems Service, Royal Edinburgh Hospital
Steven Mirin, M.D., Medical Director, American Psychiatric Association
Edward Eder, MD, Medical Director, Comprehensive Addiction Treatment Program, Fairfax, VA
J.Virgil Waggoner, Waggoner Center for Alcohol and Addiction Research, University of Texas, Austin
2:00 Charge to the Committee
Cynthia McCormick, M.D.
2:15 Continuation of Discussion
4:30 Time of Adjournment may vary