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Orphan Medical Announces FDA Approval Of Xyrem (Sodium Oxybate)

- First Medication Approved to Treat Cataplexy Associated With Narcolepsy -

MINNEAPOLIS, MN -- July 18, 2002 -- Orphan Medical, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Xyrem® (sodium oxybate) oral solution to treat cataplexy, a sudden loss of muscle tone associated with narcolepsy. Xyrem is the first approved medication indicated for the treatment of cataplexy.

Narcolepsy is a chronic neurological disorder affecting approximately 140,000 Americans. An estimated 60-90 percent of narcolepsy patients experience cataplexy. Cataplexy is a debilitating symptom of narcolepsy usually triggered by strong emotions such as laughter, anger, or surprise. In its most severe form, cataplexy can cause a person to collapse during waking hours.

Xyrem (sodium oxybate) is a central nervous system (CNS) depressant and should not be used in conjunction with alcohol or other CNS depressants. Sodium oxybate is GHB (gamma hydroxybutyrate), a known drug of abuse. The abuse of GHB has been associated with a number of important CNS adverse clinical events, including seizure, respiratory depression, and profound decreases in level of consciousness, with instances of coma and death. Even at recommended doses, use has been associated with confusion and other neuropsychiatric events. Reports of respiratory difficulties occurred in clinical trials.

Xyrem is a Schedule III controlled substance. In addition, its distribution is governed by the FDA's Subpart H regulations. To comply with these regulations, the Company has developed a rigorous system that makes Xyrem available to patients from a single, specialty pharmacy. Both physicians and patients must receive an education program from the Company before obtaining Xyrem. Orphan Medical has worked closely with the FDA, DEA and law enforcement agencies to develop strict distribution and risk-management controls designed to restrict access to Xyrem to the intended patient population. The Company has begun the hiring and training of approximately 35 additional sales employees who will call on accredited sleep centers, and other physician specialists treating those with cataplexy. The Company plans to launch Xyrem at the beginning of the fourth quarter.

"We have worked with physicians, patients, and FDA for nearly eight years to bring Xyrem to patients with cataplexy," said John H. Bullion, Orphan Medical Chairman and Chief Executive Officer. "We commend the FDA's action that recognizes the therapeutic value of this important product. We are very pleased with this long-sought approval, and we are continuing work to understand fully Xyrem's mechanism of action. We also expect to complete by the end of 2002 the clinical portion of the Phase III(b) trial designed to assess the efficacy of Xyrem in incrementally reducing excessive daytime sleepiness as a supplement to stimulant therapy."

Please join the management of Orphan Medical at 9:00 am Eastern time on Thursday, July 18th for a conference call to discuss this news announcement regarding Xyrem. The dial in numbers are 877-626-0595 (Domestic) and 706-634- 1208 (International). The pass code to enter the call is 4839700. This call is also available on the Internet at: http://www.firstcallevents.com/service/ajwz362841482gf12.html

On July 23, 2002, Orphan Medical will hold a conference call to discuss its second quarter results and provide guidance for upcoming quarters.

Orphan Medical acquires, develops, and markets pharmaceuticals of high medical value for inadequately treated and uncommon diseases treated by specialist physicians. Orphan Medical's Internet Web site address is http://www.orphan.com .

The information in this press release may contain forward-looking statements within the meaning of the Private Securities Litigation reform Act of 1995. A number of factors could cause actual results to differ materially from the Company's assumptions and expectations. These are set forth in the cautionary statements included in Orphan Medical's most recent Form 10-Q or Form 10-K filed with the Securities and Exchange Commission. (These documents can be accessed through the Orphan Medical Web site at http://www.orphan.com). All forward-looking statements are qualified by, and should be considered in conjunction with, such cautionary statements.


SOURCE: Orphan Medical, Inc.

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