JAZZ PHARMA BEGINS STUDY OF XYREM FOR FIBROMYALGIA SYNDROME
Jazz Pharmaceuticals has announced the start of a Phase III trial intended to evaluate the safety and efficacy of Xyrem (sodium oxybate) oral solution as a treatment for fibromyalgia syndrome.
The randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of Xyrem compared with placebo for the treatment of fibromyalgia and its symptoms. The study will enroll both males and females 18 and older who meet the American College of Rheumatology diagnostic criteria for fibromyalgia.
Xyrem is currently approved by the FDA for the treatment of excessive daytime sleepiness and cataplexy (the sudden loss of muscle tone) in patients with narcolepsy. Xyrem is marketed in the U.S. by Jazz Pharmaceuticals and in Europe by UCB.
In clinical trials of Xyrem, frequently reported adverse reactions included dizziness, headache, nausea, pain, somnolence and pharyngitis. Xyrem is a central nervous system and respiratory depressant and a Schedule III drug under the Controlled Substances Act.
Fibromyalgia syndrome is a chronic pain illness characterized by widespread musculoskeletal aches, pain and stiffness, soft tissue tenderness, general fatigue and sleep disturbances.
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