ACTION Needed by 10/5! Sodium Oxybate/Xyrem

Discussion in 'Fibromyalgia Main Forum' started by tig519, Oct 2, 2010.

  1. tig519

    tig519 Member

    Got this in my email from NFA (national fibro assoc)

    There is a link at the end for those who have taken another for those who have not with instructions on letters to be sent (to who) as well as the content BY OCT 5!

    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.
  2. roge

    roge Member

    I was utterly disgusted with the FDA advisory board voting 20-2 with a NO due mainly to abuse concerns. so political. i wonder how they would have voted if they or a loved one had severe fibro and wasnt being helped by any of the 3 approved fibro drugs as many are not being helped by either lyrica, cymbalata or savella.

    for many, the side effects of these drugs are too much even if they do offer some benefit. illegal street GHB has been used in the 1980's well before xyrem came on the market in 2002. studies show abuse has not risen in the time xyrem has been approved for narcolepsy in 2002 (25,000 patients using xyrem). the drug is safe. we have 8 years of data with those with narcolepsy using it. so it both works (admitted by fda panel) and is safe and is natural (molecule found in our brains and in food).

    just another slap in the face for those with fibro that this advisory panel says no mainly due to abuse potential. gimme a freakin break. there are many many drugs that have high abuse potential and are being abused but are still aprroved for medical reasons (for severe diseases). people with severe fibro have a right to choose a med that is proven to help reduce their symptom profile as well as this drug is proven in studies to increase slow wave /delta /stage3/4 sleep more than any other known drug so im not sure how they can get off with saying they disagree with Jazz's study that it doesnt improve sleep. it might not improve qauntity of sleep but it most certainly does improve the quality of sleep , this has indeed been PROVEN, and any fmer will tell you it is the quality that matters and is the biggest issue with us.

    FDA advisory panels are different than actual FDA, they tend to be more political in nature and as most know ghb has become political with the date rape issues of the past, so I trust once Jazz strengthens its risk management strategy of the xyrem, that FDA will do the right thing and approve the drug for those severe fibro.

    but lets get as many to sign this letter as possible.... to show fda and others that we are tired of being slapped in the face.

  3. tig519

    tig519 Member

    What I find interesting, is that in the studies conducted to get Lyrica approved for FMS, the results were not as favorable as Xyrem. Same holds true for Savella. The side affects of Savella specifically, have a greater risk in my opinion (increased heart rate and BP) than those of Xyrem. As with all drugs, abuse is always a possibility and shouldn't really be considered in the approval process. That's the doctor/patient responsibility.
  4. siestasuze

    siestasuze New Member

    Thanks for taking time to forward this important information!

    I emailed the letter today. Lets pray we can get their approval so we will at least have something else to try to help our pain and fatique!