Jazz Pharmaceuticals' JZP-6 To Reduce Symptoms Of Fibromyalgia

Published: 15-Jun-2009

JZP-6, the sodium salt form of gamma-hydroxybutyrate

Headquartered in California, Jazz Pharmaceuticals has declared that its pain drug JZP-6 has shown clinically significant improvement in pain and core symptoms, associated with fibromyalgia. The result was demonstrated in the phase-III trial for use of sodium oxybate (JZP-6).

Sodium oxybate is the sodium salt form of gamma-hydroxybutyrate, an endogenous neurotransmitter and metabolite of GABA.

The 14-week randomized, double-blind, placebo-controlled study included 548 adult patients with fibromyalgia randomized to one of three treatment arms, sodium oxybate 4.5g/night, sodium oxybate 6g/night or placebo. 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 (VAS).

At three months, 54.2% (p<0.001) of patients treated with sodium oxybate 4.5 g/night and 58.5% (p<0.001) of patients treated with sodium oxybate 6g/night showed significantly greater reduction in pain (as measured by at least a 30% improvement in baseline pain VAS score), compared to 35.2% of patients taking placebo.

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