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History

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The work which eventually led to the discovery of fluoxetine began at Eli Lilly and Company in 1970 as a collaboration between Bryan Molloy and Robert Rathbun. It was known at that time that the antihistamine diphenhydramine shows some antidepressant-like properties. 3-Phenoxy-3-phenylpropylamine, a compound structurally similar to diphenhydramine, was taken as a starting point, and Molloy synthesized dozens of its derivatives.[85] Hoping to find a derivative inhibiting only serotonin reuptake, an Eli Lilly scientist, David T. Wong, proposed to retest the series for the in vitro reuptake of serotonin, norepinephrine and dopamine. This test, carried out by Jong-Sir Horng in May 1972,[85] showed the compound later named fluoxetine to be the most potent and selective inhibitor of serotonin reuptake of the series.[86] Wong published the first article about fluoxetine in 1974.[86] A year later, it was given the official chemical name fluoxetine and the Eli Lilly and Company gave it the trade name Prozac. In February 1977, Dista Products Company, a division of Eli Lilly & Company, filed an Investigational New Drug application to the U.S. Food and Drug Administration (FDA) for fluoxetine.[87]

Fluoxetine appeared on the Belgian market in 1986.[88] In the U.S., the FDA gave its final approval in December 1987,[89] and a month later Eli Lilly began marketing Prozac; annual sales in the U.S. reached $350 million within a year.[87]

Rebranding and Release of Sarafem

Eli Lilly's U.S. patent on Prozac (fluoxetine) expired in August 2001,[90] prompting an influx of generic drugs onto the market. Prozac was rebranded "Sarafem" for the treatment of PMDD--Premenstrual Dysphoric Disorder--in an attempt to stem the post-patent decrease in Eli Lilly's sales of fluoxetine.[91]

This chart depicts the effectiveness of Sarafem on women suffering from PMDD as proven by 30 conducted studies. Sited Stats: Mechcatie, Elizabeth (December 1, 1999). "FDA Panel Agrees Fluoxetine Effective For PMDD". International Medical News Group

PMDD was added to the widely used psychology manual called DSM in the early 1980s. It has been reported that an average of 3-6% of women suffer from PMDD. The diagnoses of PMDD comes from the reporting of severe shifts in mood—along with common symptoms of PMS—which have had an affect on a woman’s personal life, usually happening during the luteal cycle of menstruation. After gaining the recognition from the medical community of PMDD, the pharmaceutical company Eli Lilly & Co. used the already developed drug Prozac and make minor changes to it to help treat PMDD. This new drug, Sarafem, has been marketed away from Prozac to be more appealing to the female market with a new package and color.

Following the release of Sarafem there was a flood of marketing techniques that came from Eli Lilly & Co. to sell the new drug. Eventually other pharmaceutical companies followed Lilly’s suit and did the same with their own versions of Prozac, generic or brandname, to create their own version to sell.

Before Sarafem was able to be sold on the market, many researchers and labs conducted studies to ensure that Sarafem really helped women suffering from PMDD. When Sarafem was brought before the FDA to seek approval in 1999 there had been 30 studies done to show that the majority of women within these studies had benefited from taking Sarafem. It was estimated that 60-70% of women benefitted, creating an average of 65% of women who were diagnosed with PMDD reported an improvement of symptoms after being on a regular cycle of Sarafem.

What Lilly did with the re-branding of Prozac into Sarafem was take advantage of new markets that showed significant growth potential. Sarafem did not end up doing as well in market sales as expected. The projected profit predicted by Lilly was never met and when the patent to Sarafem went up, Lilly sold the drug to Galen Holdings for $295 million dollars in cash who also saw a decrease in estimated sales of Sarafem. Such failures of such an optimistic product can be attributed to problems such as the marketing and public response to PMDD.

Some of the struggles that could attributed to the poor market response are some of the marketing failures of Sarafem. The first commercial marketing of Sarafem depicted a female struggling to release a grocery cart from a line of others and becoming increasingly frustrated and overwhelmed by the situation. As this is happening, a male voice over explains that while this woman thinks she is simply dealing with premenstrual symptoms, she is actually suffering from PMDD. This first commercial was soon removed from air after the Food and Drug Administration deemed it to undermine the seriousness of PMDD, which had already been receiving much criticism for not being a legitimate disorder. The advertisement had at the same time been criticized by feminist scholars, and the incident has since become a niche focus within feminist studies.

As of April 2, 2010, fluoxetine is one of four antidepressant drugs that the FAA allows pilots to take. The others are sertraline (Zoloft), citalopram (Celexa), and escitalopram (Lexapro).[95]

There has been research on possible effects of fluoxetine on marine life.[96]

Society and culture

Critiques of Sarafem

The modern development of PMDD, and the more recent creation of Sarafem, has been critiqued by some feminist scholars to be an industry that supports the spread of modern enlightened sexism. Some critiques about Sarafem, as supported by clinical psychologist Paula J. Caplan, are that it advertises to women who are simply experiencing PMS that they are mentally ill and need to seek unneeded medical treatment. Other researchers such as Renay Tannar have labeled PMDD and PMS as socially constructed illnesses. Such discourse has caused Sarafem, or any use of fluoxetine as a treatment for PMDD, to remain a topic of controversy when it comes to being a therapeutic drug.