US FDA approves “female Viagra”

19 Aug 2015

1

The US FDA has approved a pill for low libido in women.

Manufactured by Sprout Pharmaceuticals, the pill called Addyi (pronounced ''add-ee'') would be available in October. However, the drug to enhance sexual desire in women does not work that well and comes with side-effects.

According to The Verge, between 8 to 13 per cent of women who took the drug daily experienced an average of 0.5 more "sexually satisfying" events per month. The side-effects ranged from drowsiness to dizziness and fainting.

The drug had been rejected by the FDA twice before due to the scant benefit it offered and the side-effects that came with it. A panel had, in June, recommended putting the drug- then known by its chemical name as flibanserin- on the market with certain safety warnings.

The recent approval appeared to be influenced by the company's argument that there were 26 FDA approved drugs to treat various sexual dysfunctions for men but there was not a single for women's most common sexual complaint.

Addyi, originally developed as an antidepressant failed to show efficacy, but some test subjects reported a higher libido that led to further development of the drug for treating low sexual desire in women.

The drug is designed for premenopausal women whose lack of sexual desire causes distress in a condition formally known as hypoactive sexual desire disorder, or HSDD.

"This is the biggest breakthrough in women's sexual health since the advent of 'the Pill'" for contraception, The National Consumers League said in a statement. "It validates (and) legitimizes female sexuality as an important component of health."

However, according to Public Citizen, a consumer watchdog group, that testified against the drug earlier this year, Addyi would be pulled from the market within a few years because of "serious dangers to women, with little benefit" to them. "Unfortunately, we haven't heard the last of this drug."

Sprout's drug though nicknamed "female Viagra" in media reports, does not work like Pfizer Inc's blockbuster Viagra pill for men that in 1998 became the first approved drug for erectile dysfunction.

The drug industry's decade-long search for a female equivalent of Viagra advanced significantly when government experts recommended in June approval for a pill to boost sexual desire in women. (See: FDA panel recommends approval for female equivalent of Viagra).

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