Wednesday 7 December 2016

'Female Viagra' to boost women's libido is one step closer to US approval

A pill to help women's sex drive could be one step closer after a US panel recommended it be approved.

Hannah Furness

Published 07/06/2015 | 12:17

man and women awake in bed laughing
man and women awake in bed laughing

The development of a pill to boost women's libido is one step closer after an American panel recommended the approval of the female equivalent of Viagra.

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A panel of Food and Drug Administration (FDA) advisers has voted in favour of recommending flibanserin, a daily pill nicknamed the “female Viagra”.

The recommendation will be seen as a major coup for campaigners who have fought for women’s sex drives to receive the same level of medical attention as men’s.

The decision will now be passed to the FDA itself, which will rule on whether the pill will be officially approved for public use later this year.

While it will have no immediate effect in the UK, the lead taken by America could ease the way for similar approval to be given to drugs tackling the female sex drive on these shores. 

Flibanserin, made by Sprout Pharmaceutical, has been rejected twice by the FDA since 2010, amid concerns of its limited effectiveness. The panel noted side effects including fatigue, low blood pressure and fainting.

Experts acknowledged that flibanserin's effect is not very strong, but noted that there is a need for approved drugs to address female sexual problems.

Women taking flibanserin reported between 0.5 and 1 extra sexually satisfying event per month, compared with women taking a placebo. They also scored higher on questionnaires measuring desire and scored lower on measures of stress.

"These are very modest results," said Dr. Julia Heiman of the Kinsey Institute at Indiana University. "But on the other hand, even modest results can make a lot of difference when you're at a certain point in the clinical problem."

The recommendation for approval comes with a “risk management programme”, whereby would-be users must be alerted to its shortcomings and side effects.

It comes nearly 20 years after the approval of Pfizer's Viagra in 1998, after difficulties with women’s sexual desire proved more difficult to overcome through medical intervention.

Dozens of therapies have been studied for so-called female sexual dysfunction - an umbrella term for various problems with libido, arousal and orgasm – but have proven largely resistant to drugs that act on blood flow, hormones and other simple biological functions.

Flibanserin, which affects serotonin and other brain chemicals, was originally studied as an antidepressant, but then repurposed as a libido pill after women reported higher levels of sexual satisfaction.

More than 11,000 women have taken part in a clinical trial of the pill.

One, Amanda Parrish, a mother of four, said: "I want to want my husband, it is that simple. For us, flibanserin is a relationship-saving and life-changing drug."

The FDA panel’s recommendation comes after a lobbying campaign from supporters, including the drug manufacturers, who have criticised the lack of attention paid to female libido.

Earlier this year, a letter from campaign group Even The Score, said: “We firmly believe that equitable access to health care should be a fundamental right, regardless of whether you’re a man or a woman.

“But when it comes to sexual health – and, in particular, sexual dysfunction – that is not the case.”

Critics have pointed out the potential adverse effects of lobbying, with Dr. Adriane Fugh-Berman from Georgetown University alleging: "To approve this drug would set the worst kind of precedent: that companies that spend enough money can force the FDA to approve useless and dangerous drugs.”

If approved, flibanserin would be labelled for premenopausal women with hypoactive sexual desire disorder, described as a lack of sexual appetite that causes emotional distress. Doctors must rule out a number of alternate causes before diagnosing the condition, including depression, relationship problems and mood disorders.

Telegraph.co.uk

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