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Is Flibanserin, the Female Sex Pill, A Big Fizzle?

When flibanserin was approved by the FDA to enhance female libido, headlines announced the arrival of "female Viagra." Why hasn't the drug taken off?

An article published in JAMA Internal Medicine this week reports that the new female libido-enhancing drug flibanserin (Addyi) led to “one-half of an additional sexually satisfying encounter per month.” This was not exactly the kind of news designed to generate a great deal of excitement among physicians or their female patients. By the way, the pronunciation of Addyi is “add-ee”–not, in our opinion, a particularly catchy name for a libido lifter.

Flibanserin: A Billion Dollar Boondoggle?

In August of 2015 the large drug manufacturer Valeant Pharmaceuticals bought Sprout, a small North Carolina drug company for $1 billion cash. Sprout was truly a sprout, having only one drug of interest in its portfolio. Flibanserin (Addyi) had just been approved by the FDA for treating female sexual arousal disorder (FSAD). Doctors also call this hypoactive sexual desire disorder.

The expectations were high that this libido booster would become a big seller because millions of women were thought to be eagerly awaiting such a medication. The pundits and prognosticators were way off.

The Big Disappointment:

According to the New York Times, “The drug is not selling well.” The Times cited an analyst who projected annual sales of $11 million rather than the $100 to $150 million that was anticipated in its first year. At this rate it will take Valeant quite a while to earn back its billion-dollar investment. Don’t cry for Valeant, though. The company has been in hot water for raising prices on key generic medications. Read more about this company here.

What Went Wrong?

The approval process for this drug was long, complicated and controversial. Get The Inside Story on the Female Sex Pill Flibanserin (Addyi) at this link.

Everyone knew going in that the results of flibanserin were not all that great. The data submitted for FDA approval suggested that women who took the drug might experience one more “sexually satisfying event” each month compared to women taking a placebo. Although that is not nothing, it’s clearly not what many women were hoping for. And the new analysis in JAMA Internal Medicine concluded:

“The findings of this review suggest that the benefits of flibanserin treatment are marginal, particularly when taking into account the concurrent occurrence of AEs [adverse effects].”

The side effects mentioned in the article included: “dizziness, somnolence, nausea, and fatigue.” The authors go on to point out that the actual incidence of adverse effects is quite low.

The People’s Pharmacy Bottom Line on Flibanserin:

This drug is not a great sexual stimulant. In no way could it be considered an aphrodisiac. There is a slight enhancement, just one-half of a satisfying sexual event (or SSE) per month. Defining half an SSE might be a bit challenging, but for some women that might be better than nothing.

At the end of the day, we can only say that this drug might stimulate other pharmaceutical researchers to come up with something better. And now that the FDA has actually approved a libido-enhancing drug once, it might be more inclined to do so again, if the results of clinical trials produce more impressive outcomes.

We welcome your thoughts on this new research in the comment section below. Why do you think flibanserin has been a fizzle?

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.”.
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