Jazz Pharmaceuticals, Inc. (15809101) has recently initiated a Phase III clinical trial that will evaluate the safety and efficacy of Xyrem® (sodium oxybate) oral solution as a treatment for fibromyalgia syndrome.
The said Phase III clinical trial is a randomized, double-blind, placebo-controlled that will enroll both males and females, 18 years of age or older, who meet the American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia.
Fibromyalgia syndrome is a chronic pain illness characterized by widespread musculoskeletal aches, pains and stiffness, soft tissue tenderness, general fatigue and sleep disturbances, where pain is most commonly experienced in the neck, back, shoulders, pelvic girdle and hands, though any body part can be involved.
"Data from a randomized controlled Phase II trial of Xyrem in treating fibromyalgia showed promise that warranted conducting a Phase III trial," said Phil Perera, M.D., Vice President of Clinical Research and Medical Affairs at Jazz Pharmaceuticals.
"We look forward to further evaluating the use of Xyrem in treating fibromyalgia syndrome in this program."
Xyrem® has already been approved by the USFDA for the treatment of excessive daytime sleepiness and cataplexy (the sudden loss of muscle tone) in patients with narcolepsy.
Patients who believe they may qualify to enroll in the study; they should (or ask their physicians to) visit the Clinical Trials Website to find information on the study sites.
Source: Jazz Pharmaceuticals
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