Second Phase 3 study of sodium oxybate for fibromyalgia pain

Jazz Pharmaceuticals and UCB announced positive preliminary top-line results from the second of two Phase 3 clinical trials of sodium oxybate (JZP-6) for the treatment of fibromyalgia. This study, confirming positive results from the first Phase 3 study, was a 14-week, double-blind, placebo-controlled international trial of 573 adults randomized to one of three treatment arms: sodium oxybate 4.5 g/night, sodium oxybate 6 g/night, or placebo. Significantly more patients treated with sodium oxybate achieved the primary outcome measure, a 30 percent or greater improvement in their pain compared to patients treated with placebo. Of those patients receiving sodium oxybate treatment, 35 percent of patients on 4.5 g/night and 35 percent of patients on 6 g/night reported this level of pain relief on the Pain Visual Analog Scale (VAS), compared with 20 percent of patients on placebo. Additionally, patients’ physical functioning and ability to perform daily tasks, as measured by the Fibromyalgia Impact Questionnaire (FIQ), were statistically significantly different from placebo for both the 4.5 g/night and 6 g/night dose. Sodium oxybate-treated patients also reported highly statistically significant improvement in fatigue, another common symptom of fibromyalgia.

Sodium oxybate is the sodium salt form of gamma-hydroxybutyrate, an endogenous neurotransmitter and metabolite of GABA.  Sodium oxybate, under the trade name Xyrem, is already indicated to treat excessive daytime sleepiness and cataplexy in adult patients with narcolepsy.

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