The company’s co-founder and CEO, Cindy Whitehead, said:
It has been a remarkable journey to get to this breakthrough moment. Today we celebrate what this approval means for all women who have long awaited a medical treatment option for this life impacting condition. We applaud the FDA for putting the patient voice at the center of the conversation and for focusing on scientific evidence.
Sprout was founded in 2011 by Whitehead and her husband, Robert, when they spun out of and later sold their previous company, Slate Pharmaceuticals, to Actient Pharmaceuticals. Slate developed and commercialized a testosterone implant for men.
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A report last week in the Macon, Ga., Telegraph noted:
Slate’s marketing push ran afoul of federal rules, making misleading, unsupported statements about the benefits of testosterone therapy while downplaying risks. In fact, when the Food and Drug Administration held a meeting examining the overprescribing of testosterone last year, it played Slate’s commercial as an example of inappropriate marketing.
Sprout acquired flibanserin from Germany’s Boehringer Ingelheim, which had given up on further development of the drug in late 2010.
According to filings with the U.S. Securities and Exchange Commission (SEC), Sprout has raised approximately $100 million in five private placements. The last filing was made on June 8, 2015, and reported that five investors had purchased all $50 million worth of the equity on offer. In the first four offerings, ranging in size from $5 million to $20 million, as many as 69 investors bought equity in the company at each offering.
There are no other SEC filings for the company, so it is risky to draw any firm conclusion about an IPO. That said, however, the last round of private financing very likely included some private equity or venture capital firms that will want to recover their investment plus a hefty premium in a reasonably short period of time. Now that Addyi is available in the market, the investors will have a way to gauge how successful it can be.
It will not be altogether smooth sailing though. In a report from TIME magazine in 2009, when Boehringer Ingelheim still owned flibanserin, the executive director of women’s health advocacy group Our Bodies Ourselves said that she thinks:
[T]he diagnosis of HSDD unnecessarily medicalizes women’s sexual lives. Attempting to treat low libido with a pill ignores the fact that many women’s level of desire is deeply affected by everyday life stress and interpersonal relationships. Add to that a cultural milieu that at once promotes shame and ignorance about women’s sexuality while wildly inflating their expectations for sex.
The TIME article continues:
Yes, women are complex and so are their libidos. Which is why the quest to treat HSDD has been so fraught. It is far more difficult than, for instance, treating men’s complaints about erectile dysfunction. Viagra works simply by increasing blood flow to the penis and producing an erection. In women, the issue is not about wanting to have sex and being physically unable; rather, it’s often that women lose interest in sex altogether, especially with the partner who once excited them. Beyond the many and varied psychological roots of the problem, there is still much that is not known about the biological processes governing women’s sexual desire.
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Sprout’s announcement says, “For premenopausal women with HSDD, Addyi has demonstrated improvements in desire for sex, reducing distress from the loss of sexual desire and increasing the number of satisfying sexual events.”
Sprout also said that Addyi would available by October 17, by prescription.
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