The FDA rejected Sodium Oxybate for the treatment of Fibromyalgia

From the National FM Association:  Update on FDA rejection of Sodium Oxybate for treatment of fibromyalgia.

Here's a link to the first post I did on the topic of Sodium Oxybate for FM:  The FDA is considering approval of another new drug for Fibromyalgia that could help with sleep, fatigue and pain.

Sodium Oxybate has been rejected by the FDA so I guess that's that. Some day someone will figure out why I get NO stage 3 or 4 Delta sleep at all, ever (see Finally - sleep study results!), or they'll come up with a drug to treat the problem safely.  Until then I wait patiently, if also constantly exhausted no matter how much apparent sleep I get.

I did get a nice response from the FDA to my letter of support for Sodium Oxybate for the treatment of fibromyalgia.  It's below. The response  also contains a link to a transcript of the meeting where info was presented and discussed by a panel, and to additional meeting materials. On this web page the August 20, 2010 Meeting of the Arthritis Drugs Advisory Committee section is the one on Sodium Oxybate/Xyrem. This site includes a link to a transcript of the meeting (304 pages), and links to slides for the meeting:

FDA (129 pages)

FDA Core Presentation, Sodium Oxybate Oral Solution, for the August 20, 2010 Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee (PDF – 1.5MB)

Jazz Pharmaceuticals, Inc (152 pages)

Jazz Core Presentation, Sodium Oxybate Oral Solution, for the August 20, 2010 Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee (PDF – 2.5MB)

There is literally reams of information there. 


The FDA's response to my letter:

to Sherril Johnson    date Fri, Oct 8, 2010 at 4:50 PM

Subject RE: Letter of Support for Sodium Oxybate for the Treatment  of  Fibromyalgia

Dear Ms. Johnson,

The mission of FDA’s Center for Drug Evaluation and Research is to ensure that drugs marketed in this country are safe and effective.

FDA recognizes fibromyalgia to be a devastating disease and we empathize with the sufferers of this disease.

As part of this review process FDA held an Advisory Committee meeting on August 20, 2010, to discuss the new drug application (NDA) 22-531 for Sodium Oxybate, and the safety and efficacy findings in the fibromyalgia population.  The Advisory Committee provided FDA with independent opinions and recommendations which were advisory in nature and not binding.

We realize that Fibromyalgia is a devastating and debilitating disease with limited treatment options.  FDA takes seriously its obligation to carefully weigh all the scientific data and research, including evaluating the risks and benefits for patients, when deciding whether a product should be labeled for a particular use.  No final decision has been made regarding the approval for marketing of this product.

We encourage you to visit the FDA Advisory Committee web site for a transcript of the meeting and additional meeting material at:  http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisDrugsAdvisoryCommittee/ucm203434.htm

Thank you for making your opinions known to the Agency.

Sincerely, 

CAO

Division of Drug Information

Center for Drug Evaluation and Research

Food and Drug Administration

For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at FDA_Drug_Info

This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.