Saturday, October 9, 2010

Xyrem advocacy for sleep deficiency - The FDA reply

Xyrem may help sleep deficiency in FM and CFS. Now it is about getting the FDA to approve it. Here is their response just received in my email.

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:

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Update as of April 2015

"Adversity is only an obstacle if we fail to see opportunity."  
Celeste Cooper, RN
Author—Patient—Health Central Chronic Pain Pro Advocate
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