FDA Accepts Jazz’s Filing For JZP-6

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

Reportedly, based on a standard 10-month review, the target date for the FDA to complete its review of the NDA under the Prescription Drug User Fee Act (PDUFA) is October 11, 2010.

Jazz Pharmaceuticals said that the submission is based on a clinical development program including results from two Phase III clinical trials. In both trials, Sodium Oxybate decreased pain and fatigue as well as improved daily function, patient global impression of change, and sleep quality.

The study results suggested that Sodium Oxybate was generally well tolerated, with the majority of adverse events reported being mild to moderate in nature and similar to those seen in previous trials with narcolepsy.