Study finds Xyrem (GHB) relieves pain in patients with Fibromyalgia

[MrG]

http://www.prnewswire.com/cgi-bin/st...4287871&EDATE=

Data Presented Today at the American Academy of Pain Management Annual
Meeting

SAN DIEGO, Feb. 23 /PRNewswire/ -- Patients with fibromyalgia syndrome
taking Xyrem(R) (sodium oxybate) in a Phase II clinical trial experienced
significant pain relief, according to data presented today at the annual
meeting of the American Academy of Pain Management in San Diego.
"The pain of fibromyalgia is notoriously difficult to treat," said Patrick
B. Wood, MD, of the Louisiana State University Health Sciences Center in
Shreveport, Louisiana. "The results from this trial are quite encouraging,
and further study is warranted."
The 8-week randomized, double-blind, placebo-controlled study examined two
dosages of Xyrem (4.5g per day or 6g per day) taken in two equally divided
doses (the first at bedtime and the second 2.5 to 4 hours later). The intent-
to-treat population included 188 patients [randomized to Xyrem 4.5g, n=58;
Xyrem 6g, n=66 or placebo, n=64], of whom 147 [78%] completed the trial.
The primary outcome variable [POV] was a composite of changes from
baseline in three co-primary, self-reported measures: Pain Visual Analog Scale
[PVAS], captured with electronic diaries; Fibromyalgia Impact Questionnaire
total score [FIQ]; and Patient Global Impression of Change [PGIC].
In the intent-to-treat analysis, a statistically significant benefit in
the POV was seen in both doses of Xyrem compared with placebo [4.5g, p=0.005
and 6g, p=0.048]. Patient response rates in the POV were 34.5% [4.5g] and
27.3% [6g] compared to 12.5% in the placebo group. In the PVAS, both doses of
Xyrem resulted in significantly greater improvement than placebo [4.5g, p=0.04
and 6g, p=0.03].
In this study, Xyrem was generally well tolerated and no treatment-related
serious adverse events were reported.
The most commonly reported adverse events included nausea and dizziness
and were dose-related [4.5g, 15% and 6.7% respectively; 6g, 28.4% and 13.4%
respectively; placebo, 9.2% and 1.5% respectively]. Most adverse events were
mild to moderate in severity and transient in duration.

About Fibromyalgia
Fibromyalgia syndrome is a chronic pain illness which is characterized by
widespread musculoskeletal aches, pains and stiffness, soft tissue tenderness,
general fatigue and sleep disturbances. The most common sites of pain include
the neck, back, shoulders, pelvic girdle and hands, but any body part can be
involved.
Published data estimate that approximately 4 million Americans are
affected by the condition. Fibromyalgia affects women three times more often
than men.