FDA Approves “Female Viagra” Addyi

The experimental drug flibanserin, made by Sprout Pharmaceuticals, is at the center of a regulatory controversy.

The experimental drug flibanserin, made by Sprout Pharmaceuticals, is at the center of a regulatory controversy.

Yesterday, the Food and Drug Administration (FDA) approved Addyi (also known by its generic name Flibanserin) for public consumption. The drug, produced by Sprout Pharmaceuticals, is being touted as a “female Viagra,” a way to “even the score” sexually against men (who have many option to treat waning sexual desire). In some circles, it’s seen as a big breakthrough for women’s sexual health.

Interestingly, Addyi is the first drug to specifically treat waning sex drives for both men and women. (Viagra solved a purely medical/physical issue rather than a psychological one.) Addyi targets the central nervous system, putting it in line with an antidepressant.

Addyi purports to help women with hypoactive sexual disorder (i.e. lack of sexual desire.) But it works on a woman’s mind instead of her body. Rather than facilitating blood flow to the genital region, as Viagra does, the drug takes a two-pronged approach:

Flibanserin targets two neurotransmitters in the brain that can help inspire sexual desire. The first is dopamine, which helps control the brain’s reward and pleasure centers and could help drive up our interest in sex. The second is norepinephrine, which affects parts of the brain that control our attention and our response to things in our environment and could help direct our attention to a sexual partner.

The ultimate goal is that a woman’s level of desire would increase over time.

(Side note: Apparently, Viagra was marketed to women in 2004. The drug did increase blood flow to the women’s genitals, but didn’t affect their level of sexual desire.)

But the drug isn’t completely out of the woods yet: there are still some concerns regarding side effects. Doctors and pharmacists will need to undergo specific training of the drug before dispensing it, and will need to keep track of the women who take it. The biggest side effects include low blood pressure, sleepiness and “sudden fainting,” especially when taken with alcohol. (I have to say, I don’t really understand the point of making a drug to help with sex that can’t be paired with alcohol, but that’s just me.)

There’s also an argument that the drug “doesn’t work safely enough to justify its approval:” Women who took the drug during clinical trials reported a 37% increase in sexual desire, which averaged out to not even two more “satisfying sexual experiences” per month. The boost over the placebo group was even smaller.

It’s expected that Addyi will be covered under most health insurance plans, requiring a co-pay, and will inhabit a price range similar to that of Viagra. The drug should hit the market as soon as October (i.e. less than two months), with some outlets reporting an exact date of Oct. 17th.

I have to say, I’m really curious to see how this will do. I want to see how well it’ll perform (heh) sales-wise, and how many women report the side effects. But most of all, I want to see how this drug will influence the female-desire drugs that will surely come after it.

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