WASHINGTON, DC -- November 15, 2006 -- Pregabalin provides durable relief of pain associated with fibromyalgia, researchers reported at the American College of Rheumatology - Association of Rheumatology Health Professionals Annual Scientific Meeting (ACR-ARHP). "Six million people in the United States alone have fibromyalgia," said presenter and lead investigator Leslie Crofford, MD, professor of rheumatology and women's health, University of Kentucky Medical School, in Lexington, Kentucky. "There are no approved treatments specifically for fibromyalgia," Dr. Crofford said in a presentation on November 14th. "We report today this drug, pregabalin, shows significant benefit in terms of long-term relief of pain for patients with fibromyalgia." Pregabalin is approved by the US Food and Drug Administration for the treatment of painful diabetic peripheral neuropathy and postherpetic neuralgia. In the study, subjects went through a drug wash-out phase followed by a 6-week open-label phase. Each subject's pregabalin dosing (300, 450, or 600 mg/day) was adjusted for optimal pain control and tolerability. Of the 1,051 subjects, 93% were female and 88% were white. They had a mean age of 50 years, median duration of disease of 7.8 years and mean baseline pain score on the Visual Analog Scale (VAS) of 78 out of 100. At the end of the 6-week phase, 63% of participants achieved a greater than 50% reduction in pain and said that they were "much" or "very much improved." The investigators randomized 566 responders into a 26-week double-blind phase, where they were randomized to received either pregabalin at the optimal dosage established during the 6 weeks prior or placebo. The primary goal of the this phase was to determine the duration of therapeutic responses. In this phase, 25% of placebo subjects had worsening of disease by day 7, compared with the same percentage at day 34 for those on pregabalin. At the end of 26 weeks, 61% of placebo subjects had lost therapeutic response compared with 32% of pregabalin subjects. "This is very positive and important news for clinicians and patients dealing with this painful and often debilitating disease. It can provide durable relief for many patients," added Dr. Crofford.