News - Sodium Oxybate May Reduce Fibromyalgia Pain: Presented at AAPM

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Sodium Oxybate May Reduce Fibromyalgia Pain: Presented at AAPM

By Crystal Phend

SAN DIEGO, CA -- February 24, 2006 -- The sleep aid sodium oxybate

(Xyrem) may also help reduce pain, tenderness, and chronic fatigue

from fibromyalgia, according to a preliminary study presented here

February 23rd at the 22nd Annual Meeting of the American Academy of

Pain Medicine (AAPM). No drugs are currently approved by the U.S. FDA

for the treatment of fibromyalgia.

" Fibromyalgia is notoriously refractory to treatment, " said lead

investigator B. Wood, MD, assistant professor of family

medicine at the Louisiana State University Health Sciences Center in

Shreveport, Louisiana.

The researchers hypothesized that sodium oxybate would regulate

neurotransmitter levels required for normal sleep cycles, which are

frequently disrupted during stage III and IV sleep in people with

fibromyalgia.

" This study demonstrates a pretty novel application of this drug, "

said Dr. Wood, but he acknowledged that some clinicians have used the

drug off label for fibromyalgia.

In the double-blind, multicenter study, 150 fibromyalgia patients

were randomized to receive 4.5 g or 6 g of sodium oxybate or placebo.

They filled out a daily electronic diary reporting pain and fatigue

visual analog scale scores as well as rescue medication use. Other

measures of sleepiness, function, and global impression were recorded

at office visits throughout the 27-day study.

Both doses of the drug resulted in significant reductions in pain,

fibromyalgia impact scores, and patient-reported change in global

impression scores compared to placebo.

There was a strong trend toward significant reductions in tender

point count and tender point index. The sodium oxybate group reported

1.5 fewer tender points on average and about a 3-point reduction in

tender point index score compared with the placebo group. Sleep

scores were about 2 points lower on average for the active treatment

arm.

There was a dose-dependent increase in nausea, vomiting, headache,

and dizziness for patients receiving sodium oxybate compared with

those who received placebo.

The authors cautioned that this is preliminary, proof-of-concept

data. They are currently designing further studies to determine

sodium oxybate's efficacy in treating fibromyalgia.

Orphan Medical, a subsidiary of Jazz Pharmaceuticals, sponsored this

study.

[Presentation title: A Randomized, Double-Blind, Placebo-Controlled,

Parallel-Group, Multi-Center Trial Comparing the Effects of Orally

Administered Xyrem (Sodium Oxybate) With Placebo for the Treatment of

Fibromyalgia. Poster 121]

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