Orphan Medical Announces Patient Enrollment is Complete in Clinical Trial Assessing Xyrem for the Treatment of Fibromyalgia Syndrome

Minneapolis, MN - December 16, 2004

Orphan Medical, Inc. today announced that patient enrollment has been completed for its trial assessing Xyrem® (sodium oxybate) oral solution for the treatment of fibromyalgia syndrome.

Xyrem is currently marketed as the first and only approved treatment for cataplexy, a debilitating symptom of narcolepsy. A Supplemental New Drug Application (sNDA) filing to expand the Xyrem label to encompass improvement in the other primary symptoms of narcolepsy is expected to be submitted to the Food and Drug Administration in late December or January.

William Houghton, M.D., the Company's Chief Medical and Science Officer, stated, "We are very pleased that enrollment has been completed sooner than expected and that it has exceeded the projected requirement of 150 patients to complete the study. We still expect that initial data from the trial will be available in mid-2005."

The protocol calls for patients to complete a three-month trial with an eight-week active treatment period that will assess the impact of Xyrem on the symptoms of fibromyalgia, including the sleep disturbance that typically accompanies fibromyalgia. After a washout period, patients are randomly assigned to blinded treatment consisting of two active Xyrem doses or to a placebo arm. Approximately 20 centers located throughout the United States are participating in the trial.

Fibromyalgia is a chronic condition that is estimated to affect over four million individuals in the United States and represents a market opportunity in excess of one billion dollars per year. The disease is characterized by widespread muscle pain and stiffness and affects women three times more often than men. Other symptoms include persistent fatigue, headaches, cognitive or memory impairment, morning stiffness and non-restorative sleep.

Narcolepsy is a chronic, debilitating neurological disease.

Cataplexy, a sudden loss of muscle tone, is usually triggered by strong emotions such as laughter, anger or surprise. Patients often selectively isolate themselves from social interaction with others resulting in a worsening effect on a patient's quality of life.

Narcolepsy afflicts approximately 100,000 to 140,000 Americans with about 50,000 patients receiving some form of treatment for their symptoms. All patients with narcolepsy suffer from excessive daytime sleepiness and an estimated 60 to 90 percent suffer from cataplexy.

Orphan Medical acquires, develops and markets pharmaceuticals of high medical value for inadequately treated and uncommon CNS diseases treated by specialist physicians. Xyrem has now been assessed as a treatment for the full range of narcolepsy symptoms including excessive daytime sleepiness. The Company is also conducting a trial to evaluate Xyrem as a treatment for symptoms of fibromyalgia syndrome. Orphan Medical's Internet Web site address is www.orphan.com

The information in this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terminology such as "expects," "anticipates," "intends," "may," "should," "plans," "believes," "seeks," "estimates," "could," "would" or the negative of such terms or other comparable terminology.

Such forward-looking statements are based upon current expectations and beliefs and involve numerous risks and uncertainties, both known and unknown, that could cause actual events or results to differ materially from these forward-looking statements. 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.

Contact

Orphan Medical, Inc.
Tim McGrath, 952-513-6900 or Padilla Speer Beardsley
Matt Sullivan/Sandy Swanson, 612-455-1700