Orphan Medical Reports on Xyrem® NDA Developments

Minneapolis, MN - March 1, 2001

Orphan Medical, Inc. announced today that the FDA has canceled the March 15, 2001 Peripheral and Central Nervous System Advisory Committee review of the New Drug Application (NDA) for Xyrem® (sodium oxybate) oral solution. This committee had been scheduled to review and discuss the efficacy, safety and risk management of Xyrem. The FDA took this action in conjunction with its request for clarification of supplemental data outside of Orphan sponsored trials.

"As part of the ongoing review process we are addressing these issues, and the Company will continue its work with the FDA for thorough review of Xyrem for the treatment of narcolepsy," said John H. Bullion, Orphan Medical Chief Executive Officer. "There are three protocols currently in progress that continue the availability of Xyrem and underscore the Company's commitment to the development of this medicine."