Flibanserin (a.k.a. Female Viagra) Gets FDA Approval

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Flibanserin (a.k.a. Female Viagra) Gets FDA Approval

Flibanserin, widely known as “Female Viagra,” received FDA approval Tuesday night. Manufactured by Sprout Pharmaceuticals, the new drug aims to revive libido in women with hypoactive sexual desire disorder (HSDD).

The medication has generated a lot of controversy. Before Tuesday, the FDA had rejected flibanserin twice - in 2010 and 2013 - citing “modest” therapeutic benefits and side-effects like nausea, low blood pressure, fainting, and sleepiness.

So how did flibanserin get through the FDA this time around? Experts cite three factors:

  • Sprout conducted additional safety tests and agreed to post-market studies
  • Instead of on a daily basis, Sprout measured the drug’s efficacy over 28 days. This approach yielded a “statistically significant” effect on libido, the FDA said.
  • A public relations campaign, named Even the Score, targeted consumers with television ads, lobbied members of Congress, a sent a 60,000-signature petition to the FDA.

The agency still raises serious concerns about consuming alcohol while taking the medication. Doctors will have to undergo a training course before prescribing flibanserin, and boxed warnings will outline the risk of low blood pressure and fainting in patients who drink while taking the drug.

Supporters of the drug highlight this as a breakthrough for women’s health. Until now, there was no approved medication to sexual dysfunction in women.

“This is really a milestone moment to celebrate,” said Cindy Whitehead, Sprout’s chief executive. “There hasn’t been a whole lot of innovation in this category of women’s health since the birth-control pill [in 1960].”

Also read: The Arguments For and Against “Female Viagra”
Two Fish Walk into a Pharma Ad…

Source: http://wapo.st/1JilEHo

ClinEdge Staff

Post by ClinEdge Staff -

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