October 1, 2010
Dear NFA Supporter,
On August 20, 2010 the Food and Drug Administration (FDA) convened an Advisory Panel, made up of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee to contemplate support for the approval of Jazz Pharmaceuticals Xyrem (sodium oxybate), as a fibromyalgia treatment.
At the hearing the panel made up of medical professionals heard testimony from researchers, physicians, and patients relevant to the benefits of this medication in the treatment of fibromyalgia symptoms, especially pain. Positive scientific outcomes were expounded by the researchers. Medical doctors described the exemplary patient treatment outcomes associated with sodium oxybate.
Patients gave personal testimonies revealing their positive responses to the drug. However, even with these affirmative testimonies and shared outcome data from scientific research studies from two previous phase III trials involving a total of more than 1,000 fibromyalgia patients, that demonstrated efficacy in significantly decreasing pain and fatigue and improving daily function, the Panel voted 20 to 2 against approving sodium oxybate for the treatment of fibromyalgia.
Concerns raised by the Panel members included doing additional studies measuring sodium oxybate’s effectiveness against other FDA approved fibromyalgia drugs and instigating more Risk-Evaluation and Mitigation Strategies (REMS) control methods. Sodium oxybate is already approved by the FDA for the treatment of excessive daytime sleepiness and cataplexy (the sudden loss of muscle tone) in adult patients with narcolepsy. It is listed as a schedule III drug and its distribution is restricted through the Patient Success Program, already one of the most stringent REMS processes. Currently, it can only be purchased from a central, mail-order pharmacy and patients are first required to read a letter as well as a brochure plus watch a video about safety precautions and how to appropriately take the medication.
In response to the Panel’s rejection of sodium oxybate, Jazz Pharmaceuticals has created an even more stringent REMS program to address delivery and safety issues. It is also working with the FDA to satisfy the research questions raised by the panel.
On October 11, the next important step in the process for FDA approval of sodium oxybate will take place. Fibromyalgia patients deserve the opportunity for access to sodium oxybate to relieve their pain and other symptoms. Scientific research has shown this medication to be the most efficacious drug ever tested for people with fibromyalgia.
The NFA encourages you to please take a minute and access one of the attached letters in support of FDA approval of sodium oxybate, sign it and send it to the FDA at the provided address.
Thank you joining us, as we take action to improve the lives of people living with fibromyalgia.
Rae Marie Gleason
Executive Director, National Fibromyalgia Association