Eureka! Scientists unveil Viagra for women
A ‘FEMALE Viagra’ which works on the pleasure centre of a woman’s brain to restore flagging libido could soon be on the market.
Large-scale trials suggest that women who take flibanserin daily have sex more often and enjoy it more – although the drug has also been beset by safety concerns.
It has been endorsed by a panel of the US Food and Drug Administration in a landmark decision which should pave the way for it to be approved for sale in the US.
Manufacturer Sprout Pharmaceuticals says it is focusing on the US market, but FDA approvals are usually the first step to licensing applications elsewhere, with Europe and Britain a top priority for drugs firms.
With up to a quarter of women suffering from low libido, it is predicted to be at least as successful as Viagra, which has worldwide sales that top £2billion a year.
Flibanserin does not work in the same way as Viagra, which increases blood flow, a simple biological function. Instead, it changes brain chemistry.
However, like Viagra, which was originally designed to treat heart problems, it was formulated with another purpose in mind. It was created as an anti-depressant, but those taking part in trials said it did nothing to boost their mood yet worked wonders for their sex drive.
Despite its market potential, the drug has been hit by safety concerns and doubts over whether it is even effective.
Critics say low female libido stems from psychological as much as physical factors and they argue that the side-effects – which include dizziness, nausea, fatigue, drowsiness and insomnia – outweigh the benefits.
The FDA’s drug safety advisory committee voted 18 to six in support of Sprout Pharmaceuticals’ application but said regulators should not allow the firm to sell the medication until a strict plan is drawn up to limit safety risks.
The vote is not binding but the FDA usually follows the advice of its experts, with an official decision expected in August.
The organisation has twice rejected flibanserin in the past, but now looks likely to grant full approval after a coalition of women’s groups called for its approval.
They accused the FDA of ‘institutionalized sexism’, arguing that there was a disparity in how sexual dysfunction drugs are made available – an accusation the FDA rejected.
Amanda Parrish, a mother-of-four who took part in an 11,000-strong clinical trial of the pill, said: ‘I should be able to determine if flibanserin is worth the benefit of treatment.’
‘I want to want my husband, it is that simple,’ said Mrs Parrish, from Nashville, Ten- nessee. ‘For us, flibanserin is a relationship-saving and life-changing drug.’
Dr Julia Heiman, of the Kinsey Institute at Indiana University, said: ‘These are very modest results. 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.’
In 2010 flibanserin was rejected unanimously by an FDA panel, which said its benefits did not outweigh its risks. The following year Sprout Pharmaceuticals purchased the drug after it was dropped by its original developer, German company Boehringer Ingelheim, but it was then rejected a second time.
Before the drug can be sold in Britain it will have to be licensed by the European Medicines Agency.
Cindy Whitehead, chief executive officer of Sprout Pharmaceuticals, said: ‘We are one step closer to bringing to market the first treatment option for the most common form of female sexual dysfunction.’