The U.S. Food and Drug Administration (FDA) Anesthetic and Life Support Drugs Advisory Committee voted today 8-6 in favor of expanding the pain indications for Eli Lilly and Company's (NYSE: LLY) Cymbalta(R) (duloxetine HCl) to a broader pain population that will be further defined by the FDA, if approved.

The committee reviewed efficacy and safety data from three new Cymbalta studies in chronic low back pain and two new studies in chronic pain due to osteoarthritis of the knee, along with overall safety data for the medication. The submission also was supported by currently approved indications in the management of diabetic peripheral neuropathic pain and fibromyalgia.

While the submission was not designed to support individual indications, the committee was also asked to vote on the adequacy of evidence for efficacy in chronic low back pain and chronic pain due to osteoarthritis individually. In split votes the advisory committee was supportive of chronic low back pain based on two positive studies, but not chronic pain due to osteoarthritis based on a single positive study. The committee also voted that there was insufficient evidence of significant additional efficacy of 120 mg compared with 60 mg in these conditions.

In addition, the committee voted positively regarding the overall safety profile of Cymbalta, including potential liver toxicity, with the majority agreeing that the benefit-risk profile warrants an expanded indication.

"Lilly is committed to helping people with unmet medical needs. For people living with chronic low back pain and chronic pain due to osteoarthritis, we believe it's important they have different treatment options available since responses to medications can be highly individualized," said Robert Baker, M.D., global development leader for psychiatry and pain disorders at Lilly. "We see today's vote as an important step in potentially making Cymbalta available to a broader pain population."

About Cymbalta

Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core mood symptoms and help regulate the perception of pain. Although the exact ways that Cymbalta works in people is unknown, it is believed to be related to an increase in the activity of serotonin and norepinephrine, two naturally occurring substances in the brain and spinal cord.

Cymbalta is approved in the United States for the treatment of major depressive disorder, the treatment of generalized anxiety disorder, the management of diabetic peripheral neuropathic pain and fibromyalgia, all in adults (18+). Cymbalta is not approved for use in pediatric patients.

Indications and Important Safety Information About Cymbalta

Indications

Cymbalta is approved to treat major depressive disorder and generalized anxiety disorder, and to manage diabetic peripheral neuropathic pain and fibromyalgia.

Important Safety Information About Cymbalta

Antidepressants can increase suicidal thoughts and behaviors in children, adolescents, and young adults. Suicide is a known risk of depression and some other psychiatric disorders. Patients should call their doctor right away if they experience new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Be especially observant within the first few months of treatment or after a change in dose. Cymbalta is approved only for adults 18 and over.