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Showing posts from October, 2010

The FDA rejected Sodium Oxybate for the treatment of Fibromyalgia

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

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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 …