Xyrem for FMS/research in progress-Kaylene and Jami

[Guest guest]

Jami and Kaylene,

After I finally quit looking, I found the research material that I

was looking for that pertained to FMS and Xyrem....doesn't it always

work that way?

Dr. Scharf, Director of the Tri-State Sleep Disorders Clinic

in Cincinnati, OH, kicked off the research. He was using Xyrem for

narcolepsy patients, and found that 2 of them who had FMS showed

dramatic improvement in their pain and fatigue when on Xyrem. His

first study did not prove conclusively that it helped, but did spark

questions, so a second, more controlled study was planned.

The results of this study, which were published in May of 2003,

showed impressive results. There were overall improvements in pain,

cognition, and fatigue. The findings occurred in association with

several sleep parameters, including increased slow alpha wave

sleep. Some of the improvements that occurred were as follows

-3 of 4 pain ratings were lowered by 30% and all 3 fatigue ratings

were lowered by 32%

-time to fall asleep was less than 8 minutes

-slow wave sleep was increased 7% of the time

-There was a reduction in alpha-EEG intrustion from 37% to 26%

correlated with patient reported improvements in pain and fatigue

-there were no withdrawal symptoms or " rebound insomnia " symptoms

when the drug was stopped

-there was no loss of efficacy even after 40 months on the drug

-Xyrem is metabolized by the Krebs cycle (the same digestive cycle

that breaks down food), so it is not likely to interfere with other

meds.

-Virtually everyone responds to it.

-Many of Scharf's patients returned to their former function, and

got their lived back on track.

Now Xyrem is in a controlled research environment, with sleep

specialists testing it on people with severe sleep disorders, both

those with and without FMS, as we all know. The only fear is that

the drug will again saturate the market, and that there will be

another surge in it's sales on the black market as the " date rape "

drug. Hopefully, with its carefully controlled prescribing by

Orphan, and good screening processes in place, people's nightmares

with sleep problems will be a thing of the past.

Another interesting piece of information...the NIH was funding a

study by Northwestern University, and a company called SloWave, to

develop a drug that mimics GHB, the active component in Xyrem, in a

long acting pill with two peak releases. This drug would not be the

agent of abuse that Xyrem could potentially be, easing doctors, and

patients, fears of using it.

I hope this is the information you were looking for regarding Xyrem

and FMS, and it helps! Sorry it took me so long to come up with it!

Jen