Earlier this month, an FDA advisory committee voted to recommend the approval of flibanserin, Sprout Pharmaceutical's drug for women with persistently low sexual desire. The drug has a number of vocal critics, who believe that its side effects, relative to its modest effect, could be harmful for women.
Although many news stories about flibanserin have described it as "female Viagra," the drug actually works on the brain, not the body. Viagra (and drugs like it) improves blood flow in the penis but does not affect how a man feels desire. In contrast, flibanserin does not act on clitoral or vaginal tissues, but instead changes the activity of sexual circuits in the brain to increase a woman's desire for sex. But this shift doesn't happen for every woman who takes the drug, and some women report increased rates of fatigue, dizziness, and lowered blood pressure when they take it.
In an article at Forbes, David Kroll draws on his pharmacology training to examine whether flibanserin could be a worthwhile treatment for restoring sexual desire in the subset of women it does work on.
From the article:
In a 45-minute discussion earlier this week, Cindy Whitehead, CEO of Sprout Pharmaceuticals, told me that the drug's 'modest' effect, one that has been repeatedly shown to be statistically-significant using FDA-required tools, is being misread as 'minimal.'
Whitehead couldn't be more clear on the purpose of this drug and its performance in the clinical trials.
"'Modest' was the goal of treatment," said Whitehead. "You don't want to take a patient with HSDD and catapult them to hypersexuality. In fact, we looked at that in clinical trials because that would be an undesirable effect. So we are moving them back in a range that is their 'normal.'"
The whole article is worthwhile background reading for anyone interested in the debate, for both Kroll's analysis of the drug's side effects and drug interactions, and a discussion of the side effects from the unregulated methods some women currently use to self-treat their lack of desire. The FDA's final decision on flibanserin will occur on or before August 18, 2015.
Read the whole thing at Forbes.
Pictures: Allen G. Breed, AP Images