The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a negative opinion on a Cymbalta® (duloxetine hydrochloride) application for the treatment of fibromyalgia.
"Eli Lilly and Company and Boehringer Ingelheim are naturally disappointed by the CHMP's opinion," said James Russell, M.D., global medical director for duloxetine, Eli Lilly and Company. "We remain confident in the duloxetine data." No medication has been approved in Europe for the treatment of fibromyalgia, a disease characterized by chronic widespread pain.
The CHMP received data on the use of duloxetine in the treatment of fibromyalgia in 1,411 patients in four placebo-controlled studies and 350 patients in one open-label safety study, a total of 1,761 patients in five clinical trials.[1-5].
The cause of fibromyalgia remains unknown; however, scientists believe it may be related to some combination of genetic disposition and subsequent changes in pain processing in the brain. The disorder, which has a worldwide prevalence ranging from 0.5 percent to 5.0 percent of the population, has a high impact on quality of life. In addition to chronic widespread musculoskeletal pain, many fibromyalgia patients experience other symptoms such as tenderness, fatigue, sleep disturbance, anxiety and depression.[1,9].
In Europe, duloxetine has been approved for the treatment of diabetic peripheral neuropathic pain (DPNP), major depressive episodes, generalised anxiety disorder (GAD) and stress urinary incontinence (SUI). Duloxetine was approved in the United States for the management of fibromyalgia in June 2008 by the U.S. Food and Drug Administration (FDA).