FDA considers expanding indication for Cymbalta; side effects SJS, TEN

A Food and Drug Administration (FDA) advisory committee has narrowly voted to recommend that the indication for Eli Lilly’s antidepressant Cymbalta (duloxetine) be expanded to include use as a treatment for chronic musculoskeletal pain. The Anesthetic and Life Support Drugs Advisory Committee also voted that the benefits were minimal but outweighed the risks, which includes a black box warning of suicidality in children, adolescents and young adults; a potential for liver damage; and a risk of developing the rare skin disease Stevens Johnson Syndrome (SJS) and its more serious form, toxic epidermal necrolysis (TEN).

Cymbalta is a serotonin-norepinephrine reuptake inhibitor originally approved to treat depression. Its indication was later expanded to include fibromyalgia, anxiety, and pain associated with diabetic neuropathy. If approved, Cymbalta would be the first non-NSAID, nonopioid analgesic broadly indicated for the treatment of chronic pain.

Eli Lilly originally sought an indication for the treatment of chronic pain, but during the meeting, the advisory panel said the indication was too broad and that it would instead consider approving the drug for two types of musculoskeletal pain – lower back pain and osteoarthritis. An estimated 30 to 40 million people suffer from some type of musculoskeletal pain. If the drug is approved for the new indication, prescriptions of Cymbalta could significantly increase.

The FDA isn’t required to follow the recommendations of its advisory committees, though it usually does. In this case, it is uncertain whether the FDA will approve the new indication since an 8 to 6 vote is considered a “null” vote. One mark against Cymbalta is the drug’s marketing efforts, which were cited by the FDA earlier this year. The agency claimed Eli Lilly was overstating Cymbalta’s use against pain and minimizing its risks.