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17 November 2005

CONTACT:

National Fibromyalgia Association

Orange, Calif---November 17, 2005 - The National Fibromyalgia Association (NFA) today announced that a recent study on the narcolepsy drug Xyrem® (sodium oxybate), significantly reduces pain and improves sleep in people with fibromyalgia.

The data from an eight-week study will be presented today at the annual meeting of the American College of Rheumatology in San Diego.

"These results are very exciting because—for the first time—we have results that provide evidence that a product which improves the quality of sleep during the night also has a dramatic effect on reducing pain," said the study’s lead researcher, I. Jon Russell, M.D., Ph.D. associate professor of medicine at the University of Texas Health Science Center in San Antonio and a member of the NFA's Medical Advisory Board. "Both pain and loss of sleep are significant issues faced by patients suffering from fibromyalgia syndrome."

Fibromyalgia (FM) is a complex chronic pain illness that can lead to significant patient disability. The fact that there is no known cause or cure for fibromyalgia challenges patients and healthcare professionals alike. It is estimated that FM affects approximately six to eight million Americans and 5% of the world's population. Patients with fibromyalgia suffer from a variety of symptoms ranging from stiffness, muscle spasms and body wide pain, fatigue and severe sleep disturbances.

“This study will provide significant hope for patients searching for ways to effectively manage the chronic pain of this severe disorder,” said Lynne Matallana, president and founder of the National Fibromyalgia Association. "The NFA is very excited to support research that examines new treatment options for fibromyalgia."

Xyrem, marketed by Orphan Medical, Inc., a subsidiary of Jazz Pharmaceuticals, was approved by the U.S. Food and Drug Administration (FDA) in October 2002 as the first and only treatment for cataplexy (sudden loss of muscle tone) in patients with narcolepsy.

THE STUDY

Ø Significant benefit in the primary outcome variable (POV) was seen with both doses of sodium oxybate compared with placebo [illustrated by 4.5g, p=0.005].

Ø Sleep quality [SLP] was improved with both dosages of oxybate [4.5g, p=0.004].

Ø A significant correlation was seen between change in pain and change in sleep quality [r=0.55, p<0.001].

Ø In this study, sodium oxybate was shown to be well tolerated, as illustrated by the high rate of study completion.

Ø In the study, the most commonly reported adverse events included nausea and dizziness and were dose-related [4.5g, 15% and 6.7%, respectively; placebo, 9.2% and 1.5%].

METHODOLOGY

Dr. Russell and his colleagues, Drs. Robert M. Bennett in Portland and Joel E. Michalek in San Antonio, conducted a randomized, double-blind, placebo-controlled, multicenter clinical trial. The centers initially recruited 188 patients [placebo, n=64; oxybate 4.5g, n=58; oxybate 6g, n=66], of whom 147 [78%] completed the trial. One group took 4.5 grams of sodium oxybate per day, while a second group took 6 grams per day. The sodium oxybate was administered orally twice a day.

The POV was a composite of changes from baseline in three co-primary, self-report measures: Pain Visual Analog Scale [PVAS], captured with electronic diaries; Fibromyalgia Impact Questionnaire [FIQ]; and Patient Global Assessment [PGA]. Secondary outcome measures included changes in sleep quality [SLP]. The trial lasted eight weeks.

"These results show significant improvements when compared to placebo in the patient's sleep quality as well as the reduction of the patient's pain," stated Dr. Russell.

IMPORTANT SAFETY INFORMATION ABOUT XYREM

Sodium oxybate, the active ingredient in Xyrem, is a sodium salt of gamma-hydroxybutyrate (GHB), a substance with a history of abuse when acquired illicitly and used ilLegally. Abuse of illicit GHB has been associated with adverse CNS events including seizures, respiratory depression and profound decreases in level of consciousness, with instances of coma and death.

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. 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.®

About the National Fibromyalgia Association

The National Fibromyalgia Association (NFA) is a nonprofit [501 (c (3)] organization whose mission is to develop and execute programs dedicated to improving the quality of life for people with fibromyalgia. The NFA produces educational materials, sponsors CME and patient conferences, hosts a web site (www.FMaware.org), and publishes Fibromyalgia AWARE, the first and only consumer magazine for people with fibromyalgia, chronic pain and other invisible illnesses.

Related Links

www.JazzPharmaceuticals.com

www.FMaware.org

http://www.uthscsa.edu

http://www.fda.gov/cder/drug/infopage/xyrem/default.htm

Contact:
Corin R. Walson
Director of Public Relations & Marketing
National Fibromyalgia Association
714-921-0150 TEL
714-921-6920 FAX
www.FMaware.org