Lilly submits Cymbalta sNDA for chronic pain

US drug major Eli Lilly has submitted a supplemental New Drug Application to the Food and Drug Administration seeking approval for a new indication for Cymbalta (duloxetine HCl) for the management of chronic pain.

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 first-quarter 2008, Cymbalta generated sales of $605.1 million, a 37% year-on-year increase. The serotonin and norepinephrine reuptake inhibitor is approved in the USA 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 over 18. The agent is not approved for use in pediatric patients.