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Xyrem assessed as treatment for symptoms of fibromyalgia syndrome.

Women's Health Weekly

| October 02, 2003 | COPYRIGHT 2003 NewsRX. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

2003 OCT 2 - (NewsRx.com & NewsRx.net) -- Orphan Medical (ORPH) representatives met with clinical specialists in fibromyalgia syndrome to identify measurement endpoints for a proof-of-principle trial to assess Xyrem (sodium oxybate) oral solution as a treatment for the symptoms of fibromyalgia syndrome.

Orphan Medical expects to submit an investigational new drug application and protocol for this trial to the U.S. Food and Drug Administration later this year.

"Sleep disturbance and daytime fatigue are important components of fibromyalgia. The known impact of Xyrem on sleep architecture provides a rationale for this potential use," said William Houghton, MD, chief scientific and medical officer for Orphan Medical.

"We are seeking to address an unmet medical need as there are currently no approved medications for the ...

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