By Mechcatie, Elizabeth
Clinical Psychiatry News , Vol. 38, No. 12
The Food and Drug Administration has decided that the sedative-hypnotic drug sodium oxybate cannot be approved for treatment of fibromyalgia, based on the information currently included in the approval application, the manufacturer has announced.
The statement issued by Jazz Pharmaceuticals noted that the FDA's "complete response letter" said the new drug application for sodium oxybate cannot be approved "in its present form" and cited the need for more clinical studies. The FDA's letter also discusses the proposed Risk Evaluation and Mitigation Strategy (REMS), as well as the concentration and trade name for sodium oxybate, according to Jazz. Other topics discussed in the letter include the need for methods to ensure safe use of the drug, the sodium salt of gamma hydroxybutyrate, an endogenous neurotransmitter synthesized from gamma aminobutyric acid, which is also known as the "date rape" drug for its potent sedative effects.
It is the FDA's practice to send complete response letters to sponsors of new drug applications when there are concerns about whether the drug should be approved and to outline information needed to complete the approval process. The agency does not comment on products under review, and therefore does not release information on these letters. …