Cymbalta, duloxetine hydrochloride, was created by the same Eli Lilly researchers that were behind Prozac. David Wong and Frank Bymaster first published the discovery of the novel drug, then known as LY227942, in 1988.
The scientist wrote, “These findings suggest that LY227942 has the pharmacological profile of an antidepressant drug and is useful to study the pharmacological responses of concerted enhancement of serotonegic and norepinephrine transmission.” That means the drug stops the uptake of certain chemicals in the brain, thus increasing the amount of those chemicals in the brain artificially.
Eli Lilly and Company had the formula for duloxetine hydrochloride patented in 1991, but the drug was not approved by the FDA at that time. Lilly began research on human subjects at 20mg in 1997. Initial trials conducted in depressed patients using regimens of 20 mg/day or less did not convincingly demonstrate its efficacy as an antidepressant and the dose was increased to as high as 120mg in subsequent clinical trials done by Eli Lilly. During these trials some of the subjects committed suicide.
In November, 2001, even though some of the subjects had committed suicide, Lilly filed a New Drug Application for duloxetine for depression with the FDA. The launch of duloxetine was planned for the second half of 2002. Lilly received an approval letter from the FDA for Cymbalta for depression in September 2002. In October 2003, the FDA issued duloxetine a second approval letter saying it did not need to see any more test results before the drug got the final approval for depression.
Sixteen years after its discovery, in August 2004, Cymbalta was approved by the FDA for MDD. More than 500 sales representatives went out to help Lilly’s substantial sales force promote Cymbalta by providing free samples of the drug to physicians in the United States.
Lilly has actively promoted the drug by giving free samples to physicians and launching a huge marketing campaign to consumers. In light of the number of people who have committed suicide after taking Cymbalta, many people have questioned the safety of this powerful antidepressant and its effects on the people who take it.