Jazz Pharmaceuticals announced that the FDA has accepted for filing the New Drug Application (NDA) submitted for JZP-6 (sodium oxybate) for the treatment of fibromyalgia. This submission includes the results of two Phase 3 clinical trials where sodium oxybate significantly decreased pain and fatigue as well as improved daily function, patient global impression of change, and sleep quality.
Sodium oxybate is the sodium salt form of gamma-hydroxybutyrate, an endogenous neurotransmitter and metabolite of GABA. While the precise mechanism of action is unknown, the effects may be mediated in part through interaction with GABA(B) and GHB receptors.
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