Jazz Pharmaceuticals, Inc. announced it has submitted a New Drug Application to the FDA for JZP-6 (sodium oxybate oral solution) for the treatment of fibromyalgia. Sodium oxybate is currently marketed as Xyrem and is thus far only approved for the treatment of excessive daytime sleepiness and cataplexy associated with narcolepsy.
The submission requesting approval for the treatment of FM was based on a comprehensive clinical development program for JZP-6, including results from two Phase III clinical trials. In both trials, sodium oxybate significantly decreased pain and fatigue as well as improved daily function, patient global impression of change, and sleep quality.
Researchers have been studying Xyrem for possible use in treating FM for more than 10 years. It is thought that it works by increasing the amount of deep, restorative sleep, something that most FM patients do not get. It is during this deep sleep phase that the body refreshes and heals itself. Therefore, increasing the amount of deep sleep can result in a decrease of FM symptoms.
Once a New Drug Application has been submitted to the FDA, it generally takes about nine months to get a decision. Although some doctors are prescribing Xyrem off-label for fibromyalgia, it will probably be close to a year before we know if it will be officially approved.
Xyrem is a Schedule III controlled substance. It is a synthetic form of gamma-hydroxybutyrate (GHB), which is probably best known for its illicit use as a date rape drug. Because of Xyrem's potential for misuse and abuse, access to it is highly restricted. It is currently only available by prescription through a program called the Xyrem Success Program. It is dispensed from a single centralized pharmacy and delivered to the patient's home. The patient for whom it is prescribed must be available to sign for it when it arrives.
The most commonly reported adverse drug reactions in narcolepsy patients are dizziness, nausea and headaches. Xyrem has the potential to induce respiratory depression and neuropsychiatric events. For more information about Xyrem, see: Patient FAQs
Published On: December 21, 2009