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Xyrem Clinical Trial for Fibromyalgia Patient Enrollment Begins

  [ 676 votes ]   [ Discuss This Article ] • July 9, 2004

Orphan Medical, Inc. (Nasdaq:ORPH) announced today [June 30, 2004] that it has initiated patient enrollment in a clinical trial designed to evaluate Xyrem(R) (sodium oxybate) oral solution in the treatment of fibromyalgia. The protocol calls for 150 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 will be assigned in a randomized, blinded manner to one of two active Xyrem dosing arms or to a placebo arm. The Company expects that initial data from the trial will be available in mid-2005. Trial sites will be located throughout the United States and Canada with approximately 20 participating centers. "This trial is an important step in evaluating the potential of Xyrem in the treatment of fibromyalgia and we will work to complete this trial quickly, and if the outcome is positive, we will work with the FDA to aggressively move forward on a program for development," said John Bullion, Orphan Medical Chief Executive Officer. "There is no currently approved treatment for fibromyalgia syndrome and we believe that Xyrem could play an important role in the treatment of this substantial patient population."

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 a 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.

Orphan Medical acquires, develops, and markets pharmaceuticals of high medical value for inadequately treated and uncommon CNS diseases treated by specialist physicians. The lead product for the Company is Xyrem which is the first and only approved treatment for cataplexy associated with narcolepsy. Xyrem is also being assessed as a treatment for the full range of narcolepsy symptoms including excessive daytime sleepiness. Orphan Medical's pipeline includes development stage products for fibromyalgia and pain. Orphan Medical's Internet Web site address is

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 All forward-looking statements are qualified by, and should be considered in conjunction with, such cautionary statements. Contact: Orphan Medical, Inc., Minneapolis
Tim McGrath, 952-513-6900
David Folkens, 952-513-6994 Source: Business Wire/PR Newswire

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