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Orphan Medical announced that the total number of Xyrem® (sodium oxybate) oral solution prescriptions filled in the six-week period ended November 15, 2004 was 4,374. The Company reaffirmed its 2004 guidance of $23 to $24 million in total revenue including $10.5 to $11.0 million in revenue from Xyrem, the first and only approved treatment for cataplexy associated with narcolepsy. The Company also announced that its 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.
Narcolepsy is a chronic, debilitating neurological disease whose primary symptoms are excessive daytime sleepiness, fragmented nighttime sleep and cataplexy, a sudden loss of muscle tone, usually triggered by strong emotions such as laughter, anger, or surprise. Narcolepsy afflicts approximately 100,000 to 140,000 Americans with about 50,000 to 75,000 patients receiving some form of treatment for their symptoms. An estimated sixty to ninety percent of those with narcolepsy suffer from cataplexy. All patients with narcolepsy suffer from excessive daytime sleepiness and most from fragmented nighttime sleep.
The Company also indicated that patient enrollment continues on schedule in the clinical trial designed to evaluate Xyrem in the treatment of Fibromyalgia Syndrome. The Company expects initial data from this trial to be available in the second half of 2005.
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
Orphan Medical, Inc., Minneapolis
Tim McGrath, 952-513-6900 or
David Folkens, 952-513-6994
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