FDA Approves First Drug for Sexual Dysfunction in Women


The FDA today approved flibanserin, the first drug to treat a form of sexual dysfunction in premenopausal women.

The FDA today approved flibanserin, the first drug to treat a form of sexual dysfunction in premenopausal women.

It will be marketed as Addyi.

Though it has caught the public's attention as a "female Viagra" the controversial drug works differently than sildenafil (Viagra/Pfizer). Instead of increasing blood flow to the genitals it affects the brain, increasing levels of dopamine and norepinephrine.

It was originally developed as an antidepressant by Boehringer Ingelheim, but when in 2010 the FDA rejected that company’s application to market it in the US, the pharma company dropped it.

Sprout Pharmaceuticals, based in Raleigh, NC, acquired the drug and submitted an application to the FDA in 2013, but the agency again turned it down. Among the controversies surrounding flibanserin is the fact that unlike sildenafil it must be taken regularly, not just before a sexual encounter. It has possible side effects including nausea, sleepiness, and sudden drops in blood pressure.

The company launched a marketing campaign positioning the issue of whether to approve it as a feminist one.

The campaign featured a website called "Even the Score" which urged women to contact Congress to pressure the FDA On june 4, an FDA advisory panel recommended it be approved for treating sexual dysfunction in women.

Critics of the drug are also concerned that a lack of sexual desire in women can be caused by a number of factors that could better be treated by other therapies.

The pharma company has said the potential US market for the drug is an estimated 12 million women.

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