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.
To read the complete statement, click here.
Lynne Matallana, president and founder of the National Fibromyalgia Association, testified at the FDA hearing on Xyrem. Read the transcript of her testimony here.
Tags: FDA, fibromyalgia, Lynne Matallana, national fibromyalgia association, sodium oxybate, Xyrem
