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Saturday, October 30, 2010

The FDA rejected Sodium Oxybate for the treatment of Fibromyalgia



From the National FM Association:  Update on FDA rejection of Sodium Oxybate for treatment of fibromyalgia.

Here's a link to the first post I did on the topic of Sodium Oxybate for FM:  The FDA is considering approval of another new drug for Fibromyalgia that could help with sleep, fatigue and pain.

Sodium Oxybate has been rejected by the FDA so I guess that's that. Some day someone will figure out why I get NO stage 3 or 4 Delta sleep at all, ever (see Finally - sleep study results!), or they'll come up with a drug to treat the problem safely.  Until then I wait patiently, if also constantly exhausted no matter how much apparent sleep I get.

I did get a nice response from the FDA to my letter of support for Sodium Oxybate for the treatment of fibromyalgia.  It's below. The response  also contains a link to a transcript of the meeting where info was presented and discussed by a panel, and to additional meeting materials. On this web page the August 20, 2010 Meeting of the Arthritis Drugs Advisory Committee section is the one on Sodium Oxybate/Xyrem. This site includes a link to a transcript of the meeting (304 pages), and links to slides for the meeting:
FDA (129 pages)
Jazz Pharmaceuticals, Inc (152 pages)
Jazz Core Presentation, Sodium Oxybate Oral Solution, for the August 20, 2010 Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee (PDF – 2.5MB)

There is literally reams of information there. 


The FDA's response to my letter:





toSherril Johnson 
 
dateFri, Oct 8, 2010 at 4:50 PM
SubjectRE: Letter of Support for Sodium Oxybate for the Treatment  of  Fibromyalgia



Dear Ms. Johnson,

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:  http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisDrugsAdvisoryCommittee/ucm203434.htm

Thank you for making your opinions known to the Agency.

Sincerely, 
CAO
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration

For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at FDA_Drug_Info

This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

Wednesday, October 6, 2010

The FDA is considering approval of another new drug for Fibromyalgia that could help with sleep, fatigue and pain


Mixed media Sleeping Beauty, originally uploaded by melanie_hughes*.

The NFA is asking people with Fibromyalgia to email or fax the FDA a letter of support for approval of a new drug for FM.  The NFA has even provided a basic letter for us to use: there's one for people with FM who have taken the drug, sodium oxybate (generic name) or Xyrem (brand name), and another letter for people with FM who support approval of sodium oxybate but have not actually taken it themselves.  Go here to see my letter.  The NFA says on October 11 the next important step in the process for FDA approval of sodium oxybate will take place, so be sure to get your letters in before that date.

I've done a lot of research on this medication, before and after I tried it.  If you are wondering some of the same things I was, maybe the information and links below will help you.

An FDA panel, or advisory committee has actually already said no to sodium oxybate.  I think the actual vote is on October 11, but it's hard to tell exactly what's happening then from any of the sources I've found.

Why does politics have to be so complicated?  I really don't think it does have to be.  It's very frustrating to me.


Clinical Trial of Sodium Oxybate Results

The Fibromyalgia Network provides us with the results of the 2004-2005 clinical trials (of 188 people, an average of 35% had improvement in sleep and pain with reduction in fatigue), but at this time us regular people apparently don't get to know the results of the Stage III clinical trials which involved testing 1,050 people in 2008-2009.  In any case, I can't find  where these results are published anywhere.

35% isn't a very high number.  It's in the same efficacy range as the other three drugs that are FDA approved for FM.  This number isn't much better than that of a placebo; but if I was one of the lucky few that are helped by this medicine (like I was with Savella - except for that pesky tachycardia) I would surely put up with all the rigmarole involved in taking it (see below under "Current Prescription Procedure").


The Controversy
 
For those who aren't aware, sodium oxybate is also known as Gamma-hydroxybutyrate, or GHB, a.k.a. the date rape drug. No wonder they changed the name to Xyrem to market it this time around.

This article from about.com's Teen Advice section, Date rape drugs explained and demystified, lays the cold, hard truth on the line:
(Referring to Rohypnol, Gamma Hydroxy Butyrate (GHB) and Ketamine Hydrochloride) There are many factors that make these drugs desirable to sexual predators. The drugs are virtually undetectable; they are tasteless, odorless and colorless. All traces of the drugs will leave the body within 72 hours of ingestion and are not found in any routine toxicology screen or blood test - doctors and police have to be looking specifically for them and they have to look quickly! Date rape drugs are easily slipped into drinks and food and are very fast acting. They render the victim unconscious but responsive with little or no memory of what happens while the drug is active in their system. The drugs also make the victim act without inhibition, often in a sexual or physically affectionate way. Like most drugs, date rape drugs render a person incapable of thinking clearly or of making appropriate decisions. This makes for a very passive victim, one who is still able to play a role in what is happening but who will have no clear memory of what happened after-the-fact. Without any memory of events the victim is often unaware that they have even been raped, and if they are aware or have suspicions they make very poor witnesses.
Yes, this makes me very uncomfortable.  What if I was taking sodium oxybate and I had just taken my first or second nightly dose and a rapist came in my home and did his thing to me - and I acted like I was having a good time?  I think that's why they have you take Xyrem in two doses per night; so you are never that deeply under it's influence.  I know that the two nights I tried it, I was never that deeply asleep, but there were other circumstances for me so it's really impossible for me to have an accurate opinion. Read my personal story in my letter if you're interested in my brief experience with this medication.

In the TV shows where I've seen the effects of date rape drugs portrayed, the victims always think they've been asleep very deeply and they're hung over for some time afterward. This too would indicate a much higher dosage than what we're talking about for legitimate medicinal use.

The about.com site has a lot more information about these drugs:

 
Protecting Yourself from Date Rape Drugs

GHB
It can be easily made with common and readily available ingredients and novice chemistry skills and the recipe is easy to find.
For me, this is the deciding factor.  Whether or not this medicine is legally available to people with Fibromyalgia, there are going to be creeps and rapists out there whipping it up in their basements for nefarious uses.  So if it helps, we should have the right to choose this medicine as part of our treatment plan.


For the history of this drug, by all of its names go here.


The Current Prescription Procedure

I've never taken a med that has such a thorough safety program:

A number of measures have been put in place by Xyrem's manufacture to ensure that it is used safely and appropriately. Xyrem requires a prescription and can only be obtained through a restricted distribution program, called the "Xyrem Success Program". This restricted distribution program is required by the FDA as part of a Risk Management Program (RMP) to manage product safety and prevent abuse.[19]
The program involves many risk management components, such as:
  • Physician education
  • Registration
  • Patient education
  • Detailed patient surveillance
The program includes a single centralized pharmacy with a toll-free number.
Initial dosages are set by the prescribing physician. Each bottle of Xyrem is shipped with a graduated syringe (measured in grams) and two dosing cups. Each night, the patient mixes two doses with 60ml of water (sometimes substituted with a calorie-free beverage to cover the unpleasant taste of the medication). The first dose is taken at bedtime, and the second is taken 2.5 to 4 hours later.
http://en.wikipedia.org/wiki/Xyrem#Safety


*Thanks for Melanie Hughes for the pretty picture of the sleeping lady.

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