Flibanserin, the "Female Viagra": What You Need to Know

In 2015, the hottest new pharmaceutical release was the medication flibanserin, sold under the trade name Addyi, and known as the "female Viagra." Investors in Sprout Pharmaceuticals, the maker of the drug, were paid $1 billion for the rights to this incredibly popular drug. Just a year later, fewer than 4,000 women worldwide are using the supposed wonder-drug. What went wrong?

From a business point of view, the answer is just about everything.

How Addyi Became a Pariah Pill

One of the biggest stories in the pharmaceutical industry in 2015 was the rise and fall of Martin Shkreli, also known as the "Pharma Bro." Thirty-one year-old Shkreli, a hedge fund manager, famously obtained the license to make the anti-parasitic drug Daraprim and raised its price from US $13.50 to US $750 per tablet, leaving thousands of desperately ill users without the means to pay for the drug and without an alternative. Another company quickly provided an alternative to the incredibly expensive treatment to save lives, and the Pharma Bro was arrested for fraud in some of his other business dealings. Currently he is a political commentator for the FOX News network. His sensational activities left the public in no mood for another round of price gouging from a pharmaceutical company.

The new owners of the rights to make Addyi made nearly as many missteps with the female Viagra pill. As soon as Valeant Pharmaceuticals took over the production of the female Viagra from Sprout Pharmaceuticals, it doubled its price. To take an even larger cut of the profits from the pill, Valeant announced that it would not be available in pharmacies. The pill would only be available by mail order through a company called Philidor Rx Services. Very soon after that, Valeant announced that it would be leaving Philidor Rx Services, leaving the product without a distributor.

Because Valeant took these actions about the same time as Pharma Bro Martin Shkreli had become infamous for price manipulation of an AIDS drug, they received the attention of government regulators for predatory pricing. Multiple matters are before the courts. But there were unannounced problems with the drug much earlier.

Not Originally an Aphrodisiac

Flibanserin wasn't originally supposed to be a sexual stimulant. It was supposed to be an antidepressant, working by balancing levels of the neurotransmitters dopamine and serotonin in the brain. The original maker of the drug ran clinical trials of the medication for depression that didn't show that it worked well enough to justify its side effects such as nausea and dizziness. The FDA rejected the drug in both 2010 and 2013.

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However, the clinical trials had shown that some women who were taking the drug for depression experienced increased sexual desire. On average, the data showed, they had about one more sexual experience per month. The drug researchers seized on this as a new justification for the drug, and the FDA eventually agreed. However, there were restrictions on the medication:

• The medication would have to come with a black-box warning (the most serious kind) that it could cause dangerous drops in blood pressure if taken with alcohol.
• Doctors and pharmacists would have to take a test to prescribe or dispense it.
• The company agreed to do sex education for 18 months rather than marketing the drug directly to the public.

Does the Female Viagra Pill Really Work?

When Addyi was originally released to the market, the initial response by gynecologists was, to put it mildly, negative. As Dr. Lauren F. Streicher, a Chicago gynecologist who specializes in sexual health, was quoted in the New York Times, “Women think, ‘Wow, this one must be really bad.’” However, the company pursued a strategy of pricing the product the same as the pills used for erectile dysfunction in men so insurance companies could not avoid a claim of discrimination if they did not approve it. The strategy worked, until the company was bought out by Valeant.

A bigger question, of course, is whether the pills really work. Here's what is known.

• Addyi (flibanserin) was approved as a treatment for "acquired, generalized hypoactive sexual desire isorder" in pre-menopausal women. It was never intended for women who have had hysterectomies or who have passed menopause.
• By the time Addyi was actually approved by the FDA, the American Psychiatric Association no longer recognized "acquired, generalized hypoactive sexual desire disorder" as a treatable condition.There is a condition known as "female sexual interest/arousal disorder," although this is not precisely the condition for which the drug was approved.
• Addyi works by reducing the production of serotonin. Many antidepressants work by increasing production of serotonin. However, serotonin release at the wrong time reduces sexual desire. Addyi counteracts this effect.
• Addyi also works by increasing the product of dopamine, the brain's reward chemical. Increasing the production of dopamine increases the drive for rewarding behaviors such as sex, but also food, gambling, adventure, theft, and so on.
• The effectiveness of Addyi was measured in terms of "satisfying sexual events." This was not necessarily intercourse. Masturbation would also count as a satisfying sexual event. The average increase in satisfying sexual events was one per month.
• Only 23 percent of women taking the drug reported "greatly improved" sexual desire. In the clinical tests for Addyi, 16 percent of women taking the placebo also reported "greatly improved" sexual desire.
• The clinical trials for Addyi were limited to heterosexual women who had a partner available for sex at least 50 percent of the time. Women who had a history of endometriosis or urinary tract infections or who took antidepressants or sleep aids were excluded from the clinical trial. 

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• Addyi can't do anything about "boring" sex, lack of interest in sex on the part of the woman's partner, or problems with the attractiveness of the sexual partner.
• Much of the advertising for Addyi emphasized "evening the score," giving women a pill the way men have a pill, not about how well it worked.

What about using men's Viagra to treat women's sexual issues? Oddly enough, there is some evidence that the men's pill, which is all about "plumbing" rather than desire (which is presumed), shows some evidence of efficacy for post-menopausal women. A study of 202 women, 52 of whom were post-menopausal and 150 of whom had had hysterectomies, found that taking men's Viagra (sildenafil) significantly improved sensation and satisfaction during intercourse. It wasn't a wonder drug for women. Only 57 percent of women taking sildenafil reported improvement, compared to 44 percent taking a placebo. However, for some women, men's Viagra can improve the quality of sexual intercourse by increasing circulation to the sex organs. A "pink Viagra" is on its way to the American market.