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| |  Sodium Oxybate Improves Pain, Function in Patients With Fibromyalgia: Presented at AAPM By Jennifer Reising SAN ANTONIO, Texas -- February 9, 2010 -- Sodium oxybate significantly improves pain, produces clinically meaningful improvements in function, and is well tolerated in patients with fibromyalgia, researchers said here at the 26th annual meeting of the American Academy of Pain Medicine (AAPM). “Sodium oxybate is currently being evaluated by the FDA for the treatment of fibromyalgia,” said Robert M. Bennett, MD, Oregon Health & Science University, Portland, Oregon, on February 4. “I think it’s a very promising drug and patients who do well on it, really do well on it.” This international, randomised, double-blind, phase 3 trial evaluated the efficacy and safety of sodium oxybate oral solution compared with placebo in 573 patients with fibromyalgia who had a pain score of >=50 mm on the Visual Analogue Scale (VAS). Patients were randomised in a 1:1:1 ratio to receive sodium oxybate 4.5 g or 6 g or to placebo for 14 weeks. Treatments were administered in 2 equally divided doses at bedtime and 2.5 to 4 hours later. The primary outcome measure was the percentage of patients reporting >=30% reduction in pain VAS from baseline to week 14. Secondary measures were improvements on the Fibromyalgia Impact Questionnaire (FIQ) and Patient Global Impression of Change (PGIC) at week 14. More patients treated with sodium oxybate reported a clinically relevant pain reduction of >=30% in VAS versus placebo: 51.4% in the 6-g group and 42% in the 4.5-g group, compared with 12% in the placebo group (P <= .002). In addition, the proportion of patients with a >=50% reduction in pain was significantly higher in both sodium oxybate groups compared with placebo (P = .003). A significantly greater percentage of patients treated with sodium oxybate reported >=30% reduction in total FIQ score and a clinically meaningful improvement in global status, with PGIC scores of “much better” or “very much better,” compared with placebo (P < .001, for all). Sodium oxybate was generally well tolerated, with adverse events (AEs) mild or moderate in severity. The most common AEs with sodium oxybate (>=5% and twice placebo) were nausea, dizziness, vomiting, anxiety, somnolence, fatigue, muscle spasms, insomnia, and oedema. Funding for this study was provided by Jazz Pharmaceuticals, Inc. [Presentation title: Effects of Sodium Oxybate on Pain, Function, and PGIC in Fibromyalgia: Results From an International, 14-Week, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial. Abstract 186]
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