Prozac Case

Source: IMS New Product Spectra

Prozac (Launched Jan 1988)

Product Brief

Product Description

Prozac (fluoxetine hydrochloride) is an antidepressant for oral administration that is indicated for the treatment of depression. Launched in January 1988 by Lilly's Dista division, Prozac was the first entry in the serotonin reuptake inhibitor class (SSRI's) of antidepressants. A liquid formulation, designed for patients who cannot tolerate the 20 mg Prozac capsule, was approved in April 1991.

Market Conditions

The antidepressant market at the time of Prozac's launch was dominated by tricyclic and tetracyclic antidepressant drugs. Prozac was considered to have very few serious side effects. In fact, the possible side effect of weight loss, which was in direct contrast to the weight gain side effect of the earlier tricyclics, was considered an advantage for many depressed patients. (Prozac research capitalized on this action and investigated the use of Prozac in eating disorders.) From January through April 1988, Prozac was promoted exclusively to psychiatrists. In May 1988, Dista began Prozac details to primary care physicians. By September 1988, Prozac became the top selling branded antidepressant.

New indications, such as treatment for obesity, bulimia, smoking cessation, obsessive-compulsive disorder, and alcohol abuse, were being studied. Publicity about suicides and violent actions, by people taking Prozac, began to surface during the second half of 1990. Prozac sales remained strong, but the drug's share of antidepressant prescriptions actually declined. Lilly re-analyzed Prozac's clinical trial data for information on suicide ideation and concluded that "the emergence of serious suicidal thoughts occurred less often among people receiving Prozac, than among people receiving other antidepressants or placebo."

In May 1991, the Public Citizen's Health Research Group petitioned the FDA for Prozac to receive a black-box warning on suicide ideation. Also, the Church of Scientology (which is against the practice of psychology and the use of psychotherapeutics) waged a petition campaign to the FDA, and an intense public media campaign to have Prozac withdrawn from the market. Lilly took steps to counter this publicity. One effective step was to promise indemnity for Prozac-prescribing physicians who prescribe or dispense fluoxetine in the proper manner and who are being sued by a patient claiming personal injury from Prozac. The FDA denied both petitions and, in 1991, the FDA's Psychopharmacological Drug Advisory Committee stated that there is no reliable evidence linking Prozac with suicidal or violent behavior.

The first SSRI class competition to Prozac appeared in January 1992, when Pfizer's Roerig division launched Zoloft (sertraline), which received a 1C approval. Additional class competition occurred in January 1993, when SmithKline Beecham's Paxil (paroxetine) was launched at a 12.6% discount to Prozac pricing. In February 1994, Prozac was approved for obsessive-compulsive disorder treatment. Prozac awaits approval in the U.S. for bulimia treatment.