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Welcome to my blog, a place to explore and learn about the experience of running a psychiatric practice. I post about things that I find useful to know or think about. So, enjoy, and let me know what you think.


Thursday, August 20, 2015

Addyi-dendum


Wow! That was fast! On Tuesday, the FDA approves Addyi to treat Hypoactive Sexual Desire disorder (HSDD) in women. And on thursday, the maker of Addyi, Sprout pharmaceuticals, is sold to Valeant for $1 billion.

According to the NY Times article (link above), about $100 million has been invested in Sprout since its formation in 2011. And now it gets $1 billion. Nice.

Let's look at the sequence of events here:

Boehringer Ingelheim develops flibanserin as an antidepressant, but it doesn't work.

They notice that it increases sexual desire, so they test it for that, but the FDA rejects it in 2010, and they give up on it.

Meanwhile, Slate Pharmaceuticals, run by a couple named the Whiteheads, is selling an implantable testosterone product for men. In 2010, Slate receives a warning from the FDA for making exaggerated claims about this drug.

The Whiteheads learn about flibanserin, sell Slate, and form Sprout to acquire it.

Sprout conducts 2 studies that fail to show an increase in sexual desire, change the outcome measure, keep getting rejected by the FDA, then create Even the Score to put political pressure on the FDA to approve flibanserin on the grounds that if they don't, they are guilty of gender bias.

On Tuesday, the FDA caves to this pressure and approves flibanserin, brand name Addyi.

And today, Valeant announces that it is acquiring Sprout for $1 billion cash plus a share of future profits:

Sprout is passionate about women's sexual health and has focused solely on the delivery of a treatment option for the unmet need of premenopausal women with acquired, generalized Hypoactive Sexual Desire Disorder (HSDD)

I'm sure Sprout is as passionate about women's sexual health as Slate was about men's sexual health.

Exactly as passionate.