Agenda: Wednesday June 6, 2001
Peripheral and Central Nervous System Drugs Advisory Committee
Food and Drug Administration
Holiday Inn, Bethesda, Maryland
8:00 Call to Order, Introductions
Claudia Kawas, M.D., Acting Chair, PCNS
Conflict of Interest Statement
Sandra Titus, Ph.D., Executive Secretary, PCNS
Consideration of ( NDA) 21-196, Xyrem® (sodium oxybate, Orphan Medical, Inc.), proposed to reduce the incidence of cataplexy and to improve the symptom of daytime sleepiness for persons with narcolepsy. A main focus of the deliberations will be on risk management issues.
8:15 FDA Overview of Issues
Overview of Issues, Russel Katz, M.D., Director, Neuropharmacological Drug Products
8:30 Orphan Medical Presentations
Introduction
Dayton Reardan, Ph.D., Orphan Medical
Medical Need, Efficacy and Safety
Emanuel Mignot, M.D., Stanford University Sleep Clinic
Efficacy
William Houghton, M.D., Orphan Medical
Polysomnographic Effects of Xyrem
Jed Black, M.D., Stanford University Sleep Clinic
Safety and Summary of Risks versus Benefits
Bill Houghton, M.D., Orphan Medical
9:30 FDA Response to the Presentation
Questions from the Committee to Orphan Medical
10:00 Break
10:30 FDA Invited Speakers On Risk Management Issues
Epidemiology of GHB Abuse Issues
Carol Falkowski, Hazelden Foundation, Minnesota
Adverse Medical Effects with GHB
Jo Ellen Dyer, Pharm.D. California Poison Control System -San Francisco, University of California San Francisco
11: 00 Sponsor Presentations on Risk Management and Abuse Liability
Bob Balster, Ph.D., Medical College of Virginia
Risk Management
Patti Engel, RN, BSN, Orphan Medical
11:30 Questions from the Committee to the Invited Speakers, Sponsor and the FDA
12:00 Lunch
1:00 Open Public Hearing
2:00 Continued Committee Discussion and Deliberation
5:00 Adjourn