XYREM STUDY RESULTS REPORTED AT MEETING
Patients with fibromyalgia syndrome taking Jazz Pharmaceuticals' Xyrem (sodium
oxybate) in a Phase II clinical trial experienced significant pain relief and
improved functioning, according to data presented at the annual meeting of the
American College of Rheumatology in San Diego.
The eight-week, randomized, double-blind, placebo-controlled study examined
two dosages of Xyrem (4.5 g per day or 6 g per day) taken in two equally divided
doses (the first at bedtime and the second 2.5 to four hours later). The intent-to-treat
population included 188 patients, of whom 147 completed the trial.
In the study, Xyrem was generally well-tolerated and no treatment-related serious
adverse events were reported. The most commonly reported adverse events included
nausea and dizziness and were dose-related. Most adverse events were mild-to-moderate
in severity and transient in duration.