No studies this week, we're actually gonna do news. It's time for an Addyi update. This is Healthcare Triage News.

[Intro]

If you haven't watched our episode on Flibanserin, otherwise known as Addyi, otherwise known as the female Viagra, now would be a good time to go back and watch it.

We also covered it previously in Healthcare Triage News about a year ago. Let's recap from that one. Controversy still reigns. Many people are still arguing that the drug should not have been approved.

And here are their arguments: The drug only works in fewer than 15% of women who take it. And, when it does work, the benefit is that women should see, on average, about half an additional sexually satisfying episode per month.

And there are real side effects. One in five women will have at least one. It comes with a "black box warning" which is the highest level of alert from the FDA. The warning include low blood pressure and fainting.

Sounds... awesome. A year later things haven't gone so great for the drug, as Ed Silverman reports over its stat an advocacy group has graded the drug and the drug company to see how they are doing.

Before we get to that, let's talk some sales, because they've been somewhat less that spectacular. Back in April, Valeant Pharmaceuticals fired the contract sales force that marketed the pill. At the time, Valeant was charging $800 for a prescription, about twice what Sprout (the previous owner) had anticipated the drug would cost.

They paid a billion - with a B - in dollars for the drug. They thought they'd see that in sales in the first few months after launch. They've been cutting that forecast back again and again and again as sales have faltered.

So, how is Valeant performing in other areas? The FDA told them that they had to develop a risk management program. So far, they've got a power point and a four question test on their website. Their grade according to the advocacy group – a D.

They promised to do three new studies on the effect of alcohol and consumption in women. You may remember that the little data we had on alcohol and Flibanserin was in men, which is odd.

Anyway, they get an incomplete on that, because the studies ain't released. They were also told to conduct two pregnancy outcome related studies and submit a final protocol last March, before starting the study shortly afterward.

Since the other easier studies haven't been done yet, the advocacy group gave them an eye for incomplete on this one too. Addyi argues they're working on it but nothing's been releases yet.

Addyi is marketed to women ages 18-44, but contraindicated if you're on birth control. So, that's gonna be problematic and incomplete on birth control safety for them. And speaking of sex, women on Addyi can't take common medications for yeast infections, chlamydia, syphilis, HIV, and Hepatitis C. So, that's problematic too, a D grade there.

In the final two categories they got Fs. The first was product demand. In March 2016 there were 1500 scripts written for Addyi, compare that to about half a million for Viagra. I feel like the advocacy group is just kicking sand in Valeant's eyes there, cause why are they worried about the drug selling so poorly when they clearly don't like it.

Ditto for affordability, at 800 bucks a month it's very expensive to take on a daily basis. The bottom line is that one year later, the bad news is that the company doesn't appear to have done enough to ensure that it's being used safely. The good news I guess is that so few women are actually using it. We'll be following this closely.

[Outro]
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