FDA likely to approve this week ‘female Viagra’ to boost sagging libido of women

The US Food and Drug Administration, or FDA, would likely approve this week Sprout Pharmaceutical’s application for flibanserin, more known as the female Viagra. The drug aims to boost sagging female sex drive.

The New Zealand Herald reports that flibanserin would likely receive FDA’s green light within days. If it does get FDA approval, it would be the first medication officially sanctioned by regulators. The FDA twice rejected the drug as treatment for hypoactive sexual drive disorder.

However, it changed its mind after the FDA’s drug safety advisory committee voted for the medication’s approval because the benefits outweigh the side effects. But it said the drug could not be sold in the market until Sprout draws a strict plan to limit safety concerns.

During hearings for flibanserin, women groups came in droves to share how loss of sex drive caused anguish to their marriages, although Sprout CEO Cindy Whitehead admits the company paid for the travel of many women who attended the FDA hearings and supported the drug, reports USA Today.

Flibanserin is different from the male Viagra because it targets the pleasure centre of the female brain, not the genital. Women who took the pink pill daily during the clinical trial had sex more frequently and enjoyed it more.

However, because Spout originally created flibanserin as an antidepressant, the drug has side effects such as fainting, low-blood pressure, nausea, fatigue, drowsiness and insomnia.

Groups that backed the medication includes Even the Score, the National Organization for Women and 11 members of Congress. However, about 200 health professionals also wrote to FDA to oppose the drug’s approval, reports USA Today.

One of the letters, written by Georgetown University Medical Center associate professor Adriane Fugh-Berman, warned that if FDA approves flibanserin, it would unleash an unsafe drug on the US market and send a message that it is okay to pressure the regulator into approving a drug to get approval. She points out that lower sex drive could be due to the women’s age, fatigue caused by work, motherhood and their partners’ desire for more sex.

She accused Sprout of “medicalizing a normal condition.” She asked “Do we really need to have a corporately determined level of libido?

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