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Orphan Medical, Inc. (Nasdaq:ORPH) announced that the total number of filled Xyrem(R) (sodium oxybate) oral solution prescriptions in the past six weeks were 2,738, up 17 percent from the prior six-week period.
The Company also announced that the last patient visit for its SXB-15 Phase III(b) trial has been completed. Orphan Medical had previously announced the completion of enrollment for this trial designed to evaluate improvement in excessive daytime sleepiness (EDS) when Xyrem is used in conjunction with stimulants. Initial data from the trial is expected to be available by June of this year.
The Company noted two milestones regarding its Xyrem patent portfolio. The European Xyrem formulation patent, granted in May 2003, has completed the opposition period unopposed. Also, the United States Patent Office recently allowed a claim to the Xyrem formulation. This permits the Company to list the issued patent in the FDA's Orange Book of approved drug products and entitles the Company to the statutory protections of the Hatch-Waxman Act.
The Company also announced that it will host a live Webcast of its first-quarter results conference call on Wednesday, April 21, at 10:00 a.m. Eastern Time. The Orphan Medical management team will host the call to discuss first-quarter results.
To access the Webcast, go to the investor section of the Orphan Medical Web site at http://www.orphan.com and click on the Webcast icon. A replay of the Webcast will be available at the same address for two weeks.
Narcolepsy is a chronic, debilitating neurological disease. Cataplexy associated with narcolepsy, a sudden loss of muscle tone, is usually triggered by strong emotions such as laughter, anger, or surprise. As such, patients often selectively isolate themselves from interaction with others resulting in a dramatic effect on a patient's quality of life. 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.
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