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


Dayton Reardan, Ph.D., Orphan Medical

Medical Need, Efficacy and Safety

Emanuel Mignot, M.D., Stanford University Sleep Clinic


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