FDA Accepts New Drug Application for Sodium Oxybate as a treatment for Fibromyalgia

Jazz Pharmaceuticals have announced that the American Food and Drug Administration (FDA) have accepted their New Drug Application for JZP-6 (sodium oxybate) for the treatment of Fibromyalgia.

Last summer, positive Phase III data for Sodium Oxybate as a treatment for Fibro was presented at the 2009 Associated Professional Sleep Societies meeting.

Dr. Todd Swick, one of the study's investigators and Medical Director of the Houston Sleep Center and Assistant Clinical Professor of Neurology at the University of Texas-Houston School of Medicine, said then that:

"The data showed that sodium oxybate improves the key symptoms of fibromyalgia: pain, fatigue, and sleep disturbances...

Millions of people are diagnosed with fibromyalgia and there is a continuing unmet need for therapies that address the constellation of symptoms that can have a significant impact on patients' quality of life."

Unlike some other medications for Fibromyalgia Syndrome that primarily target pain, Sodium Oxybate works by improving sleep quality.

For more information, please see the Jazz Pharmaceuticals announcement.

If the FDA approves sodium oxybate as a treatment for Fibro, it will be the fourth drug given approval in the US as a specific treatment for Fibromyalgia Syndrome after Lyrica (Pregabalin), Cymbalta (Duloxetine) and Savella (Milnacipran).

Please note however, that sodium oxybate is NOT yet widely available as a treatment for Fibromyalgia Syndrome in either the US or the EU.

There are currently no medications with marketing approval as treatments for Fibro in the EU. Over the last 18 months, the European Medicines Agency (EMEA) has rejected applications for both Lyrica and Cymbalta to be given marketing approval for Fibro in the EU.

Both of these medications, along with many others, can however still be prescribed for UK patients with Fibro.