Jazz Pharmaceuticals Announces Phase III Clinical Trial to Study the Safety and Efficacy of Xyrem(R) (Sodium Oxybate) in Patients With Fibromyalgia Syndrome
Posted on: Thursday, 7 September 2006, 12:00 CDT
PALO ALTO, Calif., Sept. 7 /PRNewswire/ -- Jazz Pharmaceuticals announced today the initiation of a Phase III clinical trial intended to evaluate the safety and efficacy of Xyrem(R) (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 to placebo for the treatment of fibromyalgia and its symptoms. The study will enroll both males and females, 18 years of age or older, who meet the American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia.
Individuals who believe they may qualify to enroll in the study, or their physicians, should visit http://www.clinicaltrials.gov/ for information about study sites.
"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."
About Fibromyalgia Syndrome
Fibromyalgia syndrome is a chronic pain illness characterized by widespread musculoskeletal aches, pains and stiffness, soft tissue tenderness, general fatigue and sleep disturbances. The most common sites of pain include the neck, back, shoulders, pelvic girdle and hands, but any body part can be involved.
About Xyrem
Xyrem is approved by the U.S. Food and Drug Administration (FDA) for the treatment of excessive daytime sleepiness and cataplexy (the sudden loss of muscle tone) in patients with narcolepsy. Xyrem has not been approved for the treatment of fibromyalgia syndrome.
Xyrem is marketed in the United States by Jazz Pharmaceuticals and in Europe by UCB.
In clinical trials with Xyrem, frequently reported adverse reactions included dizziness, headache, nausea, pain, somnolence and pharyngitis. Less common side effects include vomiting, sleepwalking, urinary incontinence, depression and confusion. Xyrem is a central nervous system and respiratory depressant. Therefore, the use of other CNS depressants or alcohol is contraindicated in patients receiving Xyrem.
Sodium oxybate, the active ingredient in Xyrem, is a sodium salt of gamma- hydroxybutyrate, a substance with a history of abuse when acquired illicitly and used illegally. Abuse of illicit gamma-hydroxybutyrate has been associated with adverse CNS events including seizures, respiratory depression and profound decreases in level of consciousness, with instances of coma and death.
Xyrem is a Schedule III drug under the Controlled Substances Act and is only available through a restricted distribution system called the Xyrem Success Program(R). Please refer to the Xyrem package insert ( http://www.xyrem.com/ ) for full prescribing information.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals is focused on helping patients by meeting unmet medical needs in neurology and psychiatry with important and innovative therapeutic products. Jazz Pharmaceuticals is aggressively building its product portfolio through a combination of commercialization and development activities. Based in Palo Alto, California, the company is committed to working closely with patients, patient advocacy groups and healthcare professionals. For further information, please visit http://www.jazzpharmaceuticals.com/ .
Contacts: Jazz Pharmaceuticals, Inc. Matthew Fust 650-496-3777 mediainfo@jazzpharma.com Mark Leonard Next Level Communications 847-267-9660 mark@reachthenextlevel.com
Jazz Pharmaceuticals, Inc.
CONTACT: Matthew Fust of Jazz Pharmaceuticals, +1-650-496-3777,mediainfo@jazzpharma.com ; or Mark Leonard of Next Level Communications,+1-847-267-9660, mark@reachthenextlevel.com
Web site: http://www.clinicaltrials.gov/http://www.xyrem.com/http://www.jazzpharmaceuticals.com/
Source: PRNewswire
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