US FDA advisory panel narrowly votes to expand use of Eli Lilly's Cymbalta for pain

In a decision that was not widely expected given ongoing liver damage concerns, a US Food and Drug Administration advisory panel yesterday voted by a narrow eight to six to back expanded use of drug major Eli Lilly's (NYSE: LLY) antidepressant Cymbalta (duloxetine).

Notwithstanding, Lilly ' which is facing patent expiry on several of its top-selling drugs (including Cymbalta in 2013) ' saw its share price dip a further 1.5% to $34.25 in late afternoon trading. Also, there was a bit of good news for the company, which yesterday also heard that Judge Dennis Cavanaugh of District Court in Newark ordered that no generic version of the Lilly attention-deficit hyperactivity disorder (ADHA) drug Strattera (atomoxetine) be allowed on the market after the firm brought to the market for at least two weeks, after the company filed for action to give it time to appeal a negative court ruling on the drug's patent (The Pharma Letters August 16 and 18),.

In briefing papers ahead of the advisory meeting (TPL August 18), FDA staffers had raised questions about the statistical methods used to study the drug and safety concerns that include possible liver damage and bleeding risks. In the event, the FDA's Anesthetic and Life Support Drugs Advisory Committee voted in favor of expanding the pain indications for Cymbalta to a broader pain population that will be further defined by the FDA, if approved. However, after voting eight to five in favor of the drug's effectiveness for lower back pain, it voted nine to four against the drug's use for osteoarthritis. These were the two specific conditions considered in the panel's review of the drug.

In addition, the panel also expressed significant concerns about the heterogeneity of the chronic low back pain, in particular the condition that causes it. The above decisions were based on a review of efficacy and safety data from three new studies in chronic low back pain and two new trials in chronic pain due to osteoarthritis of the knee.