The Food and Drug Administration today approved a drug designed to boost sexual desire in women. The drug, flibanserin (brand name: Addyi), is made by Sprout Pharmaceuticals and works by regulating serotonin in the brain, much like selective serotonin uptake inhibitors (SSRIs). Although flibanserin is being widely referred to in the press as a “female Viagra”, the two drugs are unrelated in function and purpose. Viagra works by stimulating blood flow to the genitalia, and does not directly affect male libido. In addition, Flibanserin must be taken every day to be effective.
Flibanserin was originally developed by a German drugmaker but was rejected by the FDA in a 2010 decision because regulators felt the drug’s benefits were outweighed by its risks. The drug was again rejected in 2013, and today’s approval was aided in part by women’s lobbying groups who claimed that the FDA was employing a gender-biased double standard. Although the reported benefits of flibanserin are modest, Sprout says the drug is effective. “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,” said Cindy Whitehead, chief executive officer of Sprout. “We applaud the FDA for putting the patient voice at the center of the conversation and for focusing on scientific evidence.”
Flibanserin is approved for use by premenopausal women who suffer from hypoactive sexual desire disorder (HSDD), a condition in which a lack of sexual desire causes a person to be emotionally or mentally distressed. Sprout claims that flibanserin has a potential market of 16 million American women. Flibanserin is the first FDA-approved drug to treat HSDD.
Sprout Pharmaceuticals was founded in 2011. The company’s mission statement states that the firm is “committed to breakthrough firsts in women’s sexual health.” Sprout is a privately-held company and thus does not trade on the open market, but a rival company working on similar products rose 29 percent on Tuesday in extended trade.
Robert Hayes is a Colorado-based writer who has recently published a book on how to stay out of prison. You are invited to visit his writing and editing site.