Lilly submits new indication application to FDA for Cymbalta

INDIANAPOLIS Eli Lilly has submitted a supplemental application to the Food and Drug Administration for a new indication for the management of chronic pain for its drug Cymbalta.

Cymbalta is approved in the U.S. for the acute and maintenance treatment of major depressive disorder, the acute treatment of generalized anxiety disorder and the management of diabetic peripheral neuropathic pain, all in adults 18 years and older.

The submission is based on outcomes of clinical trials in chronic osteoarthritis pain of the knee and chronic low back pain, in addition to data from previously completed pain studies in diabetic peripheral neuropathic pain and fibromyalgia. Cymbalta was studied in chronic pain of at least moderate severity in adults who required daily treatment for an extended period of time.

In 2007, Cymbalta had sales of over $2.1 billion worldwide, according to Eli Lilly.