GlaxoSmithKline's Paxil CR (paroxetine HCl) Controlled-Release Tablets are associated with a significant reduction in symptoms and are generally well-tolerated in fibromyalgia patients, according to results from a new placebo-controlled trial released.

The study, presented at the 157th annual meeting of the American Psychiatric Association (APA) in New York, is the first to look at the benefits of Paxil CR in fibromyalgia - a chronic disorder for which there is no FDA-approved treatment.

"Fibromyalgia can be an extremely debilitating illness. Unfortunately, with no known cure or well-studied treatments, sufferers are often left to manage their symptoms with a trial-and-error approach," said Prakash Masand, M.D., a study investigator and consulting professor of psychiatry at Duke University School of Medicine. "The results of this study are encouraging because they provide clinical trial evidence that controlled-release paroxetine may reduce the symptoms of fibromyalgia."

Fibromyalgia is a chronic illness characterized by widespread musculoskeletal aches, pain and stiffness, soft tissue tenderness, general fatigue and sleep disturbances. The most common sites of pain (called "tender points") include the neck, back, shoulders, pelvic girdle, hands, knees, elbows and hip joints, but any body part can be involved. Patients experience physical and emotional symptoms that come and go over time.

Fibromyalgia affects more women than men and is seen in all age groups, although in most patients, the illness generally begins during their 20s or 30s.