Phase III data presented at SLEEP 2009 showed that Jazz Pharmaceuticals’ sodium oxybate (JZP-6) demonstrated statistically significant and clinically meaningful improvement in pain and the core symptoms associated with fibromyalgia.
“The data showed that sodium oxybate improves the key symptoms of fibromyalgia: pain, fatigue, and sleep disturbances,” said investigator Todd Swick, MD, medical director of the Houston Sleep Center. “Millions of people are diagnosed with fibromyalgia, and there is a continuing unmet need for therapies that address the constellation of symptoms that can have a significant impact on patients’ quality of life.”
The FDA or other regulatory authorities have not evaluated the data for use of sodium oxybate in the treatment of fibromyalgia.
At 3 months, 54.2% of patients treated with sodium oxybate 4.5 g/night and 58% of patients treated with sodium oxybate 6 g/night showed significantly greater reduction in pain compared with 35.2% of patients taking placebo.
The 14-week randomized, double-blind, placebo-controlled study included 548 adults with fibromyalgia. The primary outcome measure was the proportion of patients who achieved at least 30% reduction in pain from baseline to endpoint based on the Pain Visual Analog Scale.