As a participant in the FDA public hearing held on August 20 for the approval of sodium oxybate (Xyrem) for the treatment of fibromyalgia, the National Fibromyalgia Association would like to congratulate and thank the patients and physicians who also took part in the proceedings. Because of their outstanding contribution and willingness to share their personal stories, we believe the members of the panel now have a better understanding of the extensive needs for new and improved treatments for fibromyalgia.

Recent research, including the studies of Xyrem, have helped to further build legitimacy for fibromyalgia, and provide a better understanding of the complexities of the physical abnormalities within the central nervous system that play a major role in the pathophysiology of fibromyalgia. It was clear at the hearing that there continues to be a need for decision makers to be made aware of patient needs and attitudes about treatments, and their practices in utilizing medications as confirmed by published fibromyalgia research.

We are now further aware of the panel’s concern that the misuse of sodium oxybate could lead to negative consequences for fibromyalgia patients and others. However, research shows that fibromyalgia patients do not exhibit addiction tendencies. On the contrary, fibromyalgia patients are conservative in their use of pain medications.

Understandably, the NFA was very disappointed in the panel’s vote to presently deny approval of Xyrem for the treatment of fibromyalgia. Fibromyalgia patients have the right to have medications available for treatment that have great potential, as shown by in-depth clinical studies, to beneficially impact their quality of life.

Despite this current setback, we will continue to encourage and support Jazz Pharmaceuticals as they go forward to develop further safety precautions that will satisfy the FDA and lead to an approval of this important and effective drug at a future date.

The National Fibromyalgia Association is committed more than ever to continue our diligence in educating both the decision makers and the media, as well as the general public of the recent research and studies which have provided a better understanding into the symptoms, causes and issues facing people with fibromyalgia.

But we cannot do this alone. As a small nonprofit organization, the NFA needs additional funding and support to continue our work. We believe that now, more than ever before, we need to make a concerted effort to ensure that Jazz and other pharmaceutical companies will continue to have an interest in scientific research for fibromyalgia. We need to continue working with the FDA and our public officials to recognize and address the needs of the fibromyalgia community.

This takes commitment from all of us.

CALL TO ACTION

We are calling on all our supporters to

show their support in the following ways:

⎯ Make a donation to the National Fibromyalgia Association, the largest nonprofit organization dedicated to addressing and decreasing the burden of fibromyalgia through education, research and patient advocacy

⎯ If you’re a patient, encourage your healthcare providers to take an active stand in requesting the NIH (National Institutes of Health) and FDA to provide them with the appropriate knowledge and tools to better serve patients and provide improved outcomes

⎯ Participate in fibromyalgia advocacy issues and educational programs, including National Fibromyalgia Awareness Day and the NFA Leaders Against Pain.

⎯ Stay current with the NFA website by subscribing to our newsletters and Fibromyalgia AWARE magazine, where we include the latest information and news on research, treatment options and lifestyle-management guidelines.

⎯ Join the NFA’s Facebook page, where patients may find support and share positive information with one another as to how they are managing symptoms until better treatments are available

Lynne Matallana, president and founder of the National Fibromyalgia Association, testified at last week’s FDA hearing on Xyrem. Read the transcript of her testimony here.