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US regulators discuss ‘female Viagra’

viagraAdvisors to US regulators looked for a third time Thursday at the merits of a drug nicknamed the “female Viagra” because it could help increase women’s sex drive.

If the US Food and Drug Administration gives flibanserin the go-ahead, it would be the first drug on the market designed to boost female libido.

But two attempts at bringing the drug to market have already failed in 2010 and 2013, given what experts described as inconclusive advantages when compared to a placebo.

Flibanserin, which is aimed at pre-menopausal women, also can have significant side effects including nausea, dizziness and sleepiness.

On Thursday, a committee of advisors to the FDA heard more evidence from clinical studies and from experts both for and against the drug.

“The treatment effects are numerically small,” said doctor Christina Chang, speaking to the panelists on behalf of the FDA, adding that the committee would be asked to weigh in on the evidence of benefits and risks in women studied.

Safety concerns included sleepiness, fainting, low blood pressure and the potential for hormonal contraceptives and alcohol use to make side effects worse, Chang said.

Experts at the hearing also raised questions about the possibility for the treatment to be used as a “date-rape drug” and the increased risk of breast cancer seen in one of two studies on lab animals.

The committee will vote at the end of the day on whether the FDA should approve the drug, a decision that is non-binding but is usually followed by the regulatory agency.

– Rejected before –

After it was initially rejected by the FDA, flibanserin was sold by its developer, the German laboratory Boehringer Ingelheim, to a US firm called Sprout Pharmaceuticals.

Cindy Whitehead, the CEO of Sprout Pharmaceuticals, has said previously that “we feel quite firmly that flibanserin’s modest effect is a meaningful effect,” and that the drug will not have an immediate effect on women’s desire.

For this latest attempt at approval, Sprout Pharmaceuticals is presenting research that shows the medication does not affect women’s ability to drive.

According to documents on the FDA website that describe a previous study of the drug, women taking flibanserin reported on average 4.4 sexually satisfying encounters per month, compared to 3.7 in a placebo group and 2.7 before beginning the study.

The difference between flibanserin and a sugar pill was deemed statistically insignificant in 2010 after a debate among the committee members which included seven women and four men.

The aphrodisiac properties of flibanserin were discovered accidentally when it was tested as an anti-depressant, the drug-maker says.

Viagra’s ability to cause an erection was discovered after it was tested as a heart medication. Other big drug companies have already thrown in the towel when it comes to developing a female version, including Pfizer and Procter and Gamble.

Some experts have said that no drug can possibly resolve the emotional complexities that make up female sexual desire.

Research has shown that at least 40 percent of women suffer to some extent from low sex drive.

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