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.