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It has been more than a year since flibanserin, the "female Viagra," has been approved for use. Does it really work?

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.

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.
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