Duloxetine: A Dual-Action Antidepressant
A new “dual-action” antidepressant is expected to be a blockbuster drug for Eli Lilly & Co. With the launch of drug duloxetine (Cymbalta™), the company hopes to reclaim the throne it lost when its tablet fluoxetine (Prozac®) lost patent protection and became generic two years earlier than expected in 2001. Generic Cymbalta is reaching the market more than a year later than Lilly had hoped because of regulatory delays linked to problems in the company’s manufacturing facilities.
The agent differs from the most widely used class of antidepressants, which affect only serotonin levels in the brain. It targets two brain chemicals thought to play a role in depression and mood— norepinephrine and serotonin.
This is the first new antidepressant to be approved since the debate exploded over the drugs and the possible increased risk of suicide, especially among youths. Like most other antidepressants on the market, Cymbalta™ includes a warning about suicide risk on its label, but it has not yet been tested in children.
Lilly is also seeking approval for the drug to treat stress urinary incontinence.
