The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a negative opinion for a Cymbalta® (duloxetine hydrochloride) application for the treatment of fibromyalgia.
Eli Lilly and Company and Boehringer Ingelheim are naturally disappointed by the CHMPs opinion, said James Russell, M.D., medical director, 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