FM Awareness Day; New Drug Research Reviews

Sorry everyone, I know FM/CFS Awareness Day is technically over...
But thought I'd post anyhow.

I did a lot of FM/CFS-related posts on my personal Facebook page, but wore myself out before I could make it here. Today I got an e-mail on FM news stories that mentioned two drugs; one I'd heard little about, and another I'd never even heard of, Sodium Oxybate (aka Xyrem aka GHB) and Flupirtine.

I found this article on Flupirtine, and was astonished to read how GREAT it sounded as a treatment for FM. A non-narcotic, non-NSAID analgesic that also helped with energy! I got really excited. Then I looked at the date on the article. and saw it was dated in the year 2000, much to my disappointment. Apparently this drug has been available for a couple of decades in Europe. So what I want to know now, is why is this the first I'm hearing of it? I still have to do some follow-up research to see if I can find the answer, but I'm guessing it will be FDA/Big Pharma red tape -related.

The second drug, which vaguely rang a bell, after a quick Google search to refresh my memory, is being prepared for marketing under the brand name Xyrem. I also found out that it is basically GHB...Better known as "The Date Rape Drug".

I thought, WOW. Are they serious with this? Do they know about Fibro fog? It just seemed like a bad move, a VERY bad move, to prescribe a drug that makes date rape victims forget what happened, as well as being effective in making making people forget traumatic experiences. My first thought was, not a chance I'd try that! I then did a search on memory and GHB, and found this article, which explained the effects of it on people with FM/CFS.
Sounds AMAZING. The main mechanism by which it works seems to be by quieting the overactive nervous system of people w/FM/CFS. It also seems to help with anxiety, as the article mentions. (I'm a total anxiety ball, and I've often wondered if day after day and year after year of pushing past all that anxiety (I rarely let it stop me) had something to do with my body beginning to betray me, that the stress helped run me down and make/keep me sick.
Here's a link about Xyrem & FM; note the main point:

"Some people already take Xyrem, off label, for fibromyalgia and anecdotal evidence supports its use. Clinical trials have shown that the drug can significantly improve sleep quality and reduce pain in people with this condition. The first 2 Phase III trials have been wrapped up but the findings are not yet released. Jazz Pharmaceuticals submitted a New Drug Application to the FDA in late 2009."

Hence, probably not the right drug for me, I already sleep decently (aside from staying too late.) And my pain is currently manageable. To learn more about Xyrem, check otu this article: http://chronicfatigue.about.com/od/treatingfmscfs/p/sodiumoxybate.htm


That's all folks...falling asleep here,now, yay!!!!!!
Oh, did wanna mention that I made it to the gym today! So it's ON! Well...guess I should wait & see how tomorrow feels....but I'm optimistic and can't wait to work of some more of the pounds I've accumulated!

Hope you all had a great Awareness Day & did your part! And if you live in Southern California, try & make it to the NFA's even on Saturday!

FDA Gives Milnacipran Green Light for Fibromyalgia Treatment

Interested in seeing how this works on real people. Not that I could probably afford it anyhow, since my insurance has a brand name drug deductible of $500...What are your thoughts?

FDA Gives Milnacipran Green Light for Fibromyalgia Treatment – Third to Be Approved, After Lyrica and Cymbalta
January 15, 2009

The drug milnacipran (to be marketed under the brand name Savella™) received FDA approval as a prescription treatment for symptoms of fibromyalgia (FM) on January 14, 2009 – and reportedly will be available in U.S. pharmacies by March.

Milnacipran – a selective serotonin and norepinephrine dual reuptake inhibitor (SSNRI) developed as an antidepressant – has been tested in multiple trials for ability to demonstrate concurrent improvement in FM pain, physical function, and overall impression of change (global assessment).

Trials Measured “Global” Symptom Status
Generally, more trial subjects taking milnacipran than subjects taking placebo reported “at least a 30% reduction in pain from baseline and also rated themselves as ‘very much improved’ or ‘much improved’ in the global assessment,” according to a release by the drug’s developer, Cypress Bioscience (San Diego), and Forest Labs (New York), which owns the rights to milnacipran in the U.S. and Canada.

Milnacipran “is the only product approved for the management of fibromyalgia that used this complete responder analysis as its primary endpoint,” observes Cypress Bioscience CEO Jay D. Kranzler, MD, PhD.

“The introduction of Savella is important because it is the first drug approved to treat the symptoms of fibromyalgia using a composite responder analysis,” notes fibromyalgia pain specialist and researcher Dr. Daniel Clauw, Professor of Anesthesiology and Medicine (Rheumatology) at the University of Michigan, Ann Arbor.

May Address “Abnormalities in Certain Brain Neurotransmitters”
“Although the exact mechanism by which Savella improves the symptoms of Fibromyalgia is unknown, some researchers believe that abnormalities in certain brain neurotransmitters may be central to fibromyalgia," the news release states. "Savella blocks the reuptake of both norepinephrine and serotonin, with greater selectivity for the inhibition of norepinephrine reuptake in vitro. This may be the mechanism by which Savella acts to improve the symptoms of fibromyalgia.”

As with all potent drugs, milnacipran is not without potential side effects and contra-indications, as detailed in the Cypress Bioscience/Forest Labs news release under “Important Safety Information.”

from: http://www.prohealth.com/fibromyalgia/library/showarticle.cfm?libid=14247