Eli Lilly Withdraws Cymbalta ApplicationDec 1, 2008 | Parker Waichman LLP Cymbalta, already approved as an anti-depressant, faced questions from U.S. health regulators over efficacy and dosage recommendations.
Lilly said its move to pull the supplemental New Drug Application (NDA) for Cymbalta—known generically as duloxetine HCl—was prompted by FDA reviewers' questions regarding “the design of supporting Lilly studies and statistical methodology,” said Reuters. The report said that Lilly plans to resubmit its application in early 2009, “after adding data from a recently completed study in chronic osteoarthritis pain of the knee.”
The recent decision does not affect Cymbalta’s current FDA-approval for the drug’s use for major depressive disorder, generalized anxiety disorder (DAD), management of diabetic peripheral neuropathic pain, and management of fibromyalgia, Lilly told Reuters.
As an antidepressant, Cymbalta has raised safety concerns. When the FDA issued a prior warning about the potential for suicidal thinking in adults taking antidepressants, it specifically singled out Cymbalta because of a higher than expected suicide attempt rates revealed in studies. Cymbalta has been associated with suicide risk since its clinical trials and one review of Cymbalta found that 11 of nearly 9,000 women taking it for urinary incontinence tried to commit suicide. The fact that these patients were suffering from urinary incontinence and not depression is significant because the drug companies have long argued that antidepressants are used by depressed people who experience a higher likelihood of committing suicide.
Concerns about suicidal behavior surfaced in 2004 when Traci Johnson, a healthy volunteer involved in a trial at Eli Lilly's clinic at Indiana University Medical Center in Indianapolis, killed herself in one of the clinic’s showers. Johnson, who did not suffer from depression, was taken off the drug and given a placebo four days before she hung herself in one of the clinic's showers. She was the fifth patient to commit suicide after taking Cymbalta in clinical trials. After her death, one-fifth of the volunteers quit the Cymbalta trial.
The FDA began reanalyzing hundreds of studies of the drugs and told makers to add or strengthen suicide-related warnings on their labels in the meantime. Since then, several new studies have been published in medical journals about a possible connection with suicidal behavior.