FDA Approves New Antidepressant Drug
August 04, 2004
WASHINGTON (AP) - The Food and Drug Administration approved sale of a new antidepressant for adults on Wednesday. Called Cymbalta, it should be on pharmacy shelves by late month.
Maker Eli Lilly & Co. is banking on Cymbalta as a successor to its once-blockbuster Prozac. Cymbalta, known chemically as duloxetine, is one of a newer class of antidepressants that targets two brain chemicals involved in depression, serotonin and norepinephrine.
It's the first antidepressant to hit the market since the FDA began investigating whether such drugs sometimes can increase the risk of suicide, particularly when used by teenagers, or if patients' underlying depression is to blame.
Cymbalta initially wasn't part of that still-ongoing debate. But it gained attention in February when a college student taking part in a study of the drug hanged herself in a company research facility. Lilly insists there's no evidence Cymbalta was to blame.
FDA closely scrutinized research on Cymbalta, looking at any suicides or suicidal behavior ``on a case-by-case basis,'' and found no difference in the rate between users of the drug and those given a dummy pill, said Dr. Paul Andreason, the agency's primary reviewer.
But like all similar antidepressants, Cymbalta's label does bear a stern warning that doctors and families should closely watch patients for warning signs of suicide - including agitation, anxiety or hostility - especially when they first start the pills or change a dose.
Cymbalta is approved to treat major depression for up to nine weeks. In one study, Cymbalta users were almost three times as likely to achieve remission of their depression as patients given a dummy pill, said Lilly's Dr. Madelaine Wohlreich.
Cymbalta's average wholesale price will be $2.85 for 60 milligrams, the usual daily dose, which Lilly called comparable to similar competitors.
Lilly also is studying the drug as a possible treatment for stress urinary incontinence.