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What You Should Know about “Female Viagra”

March 03, 2021
Those little blue pills are ubiquitous…in commercials featuring couples of a certain age, in the punchlines of late-night talk show hosts and even in celebrity headlines. Whether it's Viagra, Cialis or Levitra, men have had a way to "get back in the game," as pitchman Mike Ditka encourages, since 1998 when the Food and Drug Administration approved Viagra.

Women who have similar libido issues have been excluded from the game – until now. Addyi, or flibanserin, is marketed as "the first of her kind" by its creator, Sprout Pharmaceuticals. An erection obviously isn't the problem for women, but Hypoactive Sexual Desire Disorder (HSDD), the disorder for which Addyi is indicated, might be. HSDD is classified in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) under the category of Female Sexual Interest/Arousal Disorder.

“HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. HSDD is acquired when it develops in a patient who previously had no problems with sexual desire. HSDD is generalized when it occurs regardless of the type of sexual activity, the situation or the sexual partner,” according to the FDA's August 2015 press release about the breakthrough drug.

So why did the FDA reject it in October 2014, and what changed the organization's mind?

Praise for Addyi

Dr. Janet Woodcock, Director of the FDA's Center for Drug Evaluation and Research claimed in the press release: “Today's approval provides women distressed by their low sexual desire with an approved treatment option.”