Let’s talk about Addyi. Addyi is a new drug available for treatment of hypoactive sexual desire disorder. The condition means what it says; it is premenopausal women who have a decrease in their desire for sex that causes some significant distress and causes and interpersonal relationship problems. As with anything else in medicine, we have to exclude certain other causes. So it’s not associated in this case with either depression, anxiety, other medical conditions (for instance cancer, heart disease, lung disease); it’s not associated with having major problems in your relationship; and it’s not associated with taking other medicines that might interfere with your interest in having sex.
Overall it seems that sexual disorders are occurring anywhere between maybe about 10 and 40 percent of women. And if we look at hypoactive sexual desire disorder in premenopausal women, maybe about 10% of all women or 5 million to 6 million women here in the United States.
The pill Addyi or flibanserin is a pink pill. A lot of people call it the pink Viagra or the female Viagra but it’s not. Viagra, the blue pill is for men. It increases the blood flow to the penis and can be taken whenever one wants to have sexual relations as opposed to the Addyi that has to be taken on a daily basis. And it works on the brain; it works to increase certain neurotransmitters, certain chemicals in the brain (dopamine and norepinephrine), and it decreases the amount of serotonin, supposedly that’s what makes it work. But we really don’t know that would be correct.
The drug was originally developed by a German pharmaceutical manufacturer. They tried it for depression, and it didn’t seem to work. So they tried it for hypoactive sexual desire disorder, ran into some problems with food and drug administration. So they gave up on the pill. Then the pill was sold to a company known as Sprout Pharmaceuticals. Sprout Pharmaceuticals tried to get the FDA to approve it, ran into some roadblocks. So they mounted a major campaign called even the score, they claimed that there was sexism at the Food and Drug Administration. They claimed that there were 26 medicines available for men who had difficulty with sex, but that’s Viagra and testosterone and the related compounds. They have lots of women’s groups that were actively militating for approval of this medication. They even had people going out and tweeted, some of them were doctors who were even being paid by the company. That was unknown to the people who were reading all of the tweets.
So in the end result, they presented the evidence to the food and drug administration, and they said that they could increase the number of sexually satisfying experiences by one a month. That’s right. Not a major improvement. One a month. That’s barely scientifically meaningful.
So the food and drug administration considered the evidence an advisory committee in June of 2015 and said: “Well, okay, you can approve it.” They voted 18 to 6 in favor of approval. That went on to the full food and drug administration that in August of 2015 approved the drug and within 48 hours after they approved the drug, guess what? The company was sold to Valeant Pharmaceuticals for 1 billion dollars.
Now Valiant has had lots of problems recently with some ethics, with some price raises, price increases. They are being investigated by the Senate, they’re being investigated by the SEC, they have lots of problems with some of the other medicines, they have problems with their marketing approach. The company said that they would pay 500 million dollars cash right it’s signing, another 500 million dollars in early 2016 and then some extra money depending on whether the drug met its milestones. But unfortunately, it isn’t meeting its milestone.