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FDA Cancels review of GHB-- from or

Posted by Christy Ann on March 03, 2001 at 13:28:37:




FDA Cancels review of GHB-- from orphan medical!


ORPHAN MEDICAL REPORTS ON XYREM® NDA DEVELOPMENTS
March 1, 2001.

MINNEAPOLIS– 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.”

Narcolepsy is a chronic neurological disorder affecting an estimated 100,000 to 125,000 Americans, whose main symptoms are excessive daytime sleepiness and cataplexy. Cataplexy is a debilitating symptom characterized by loss of muscle control in response to strong emotional reactions such as laughter, anger, or surprise. In its most severe form, cataplexy can cause a person to collapse during waking hours.

ALL CONTENT COPYRIGHT © 2000 ORPHAN MEDICAL

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