Female viagra ‘to get the green light’
...but drug is still plagued with safety risks
A DRUG dubbed the ‘female Viagra’ is set to be approved by a US watchdog this week – paving the way for its arrival in the UK.
Industry experts claim flibanserin could be given the green light within days, making it the first officially sanctioned drug for low female sex drive on the market.
Unlike its male equivalent, the drug combats a flagging libido not by targeting the genitals but the pleasure centre of a woman’s brain, with women who took the pill every day in trials having sex more frequently and enjoying it more.
However, the drug has been plagued by safety fears.
Large-scale trials by manu- facturers Sprout Pharmaceuticals found the pill – originally created as an antidepressant – was linked to side effects such as fainting and low blood pressure, nausea, fatigue, drowsiness and insomnia.
Critics have also pointed out that low female libido stems from psychological as much as physical factors.
Despite previously rejecting flibanserin twice because of these side effects, the US Food and Drug Administration is now expected to give the drug the go-ahead as a treatment for hypoactive sexual desire disorder (HSDD) – a persistent lack of sexual desire in women.
The FDA’s drug safety advisory committee has already voted in favour of its approval, after saying the benefits outweighed the risks – although it ruled regulators should not allow the medication to be sold until a strict plan is drawn up to limit safety concerns.
The US watchdog usually – but not always – follows the decision of its panel of experts. After the initial rejections the FDA came under pressure from women’s organisations who claimed it was guilty of ‘institutionalized sexism’ for prioritising sexual dysfunction drugs for men.
Once the drug gains approval in America, Sprout Pharmaceuticals has indicated it could turn its attention to Europe, including the UK. However before the drug can be sold in Britain it will have to be licensed by the European Medicines Agency.
With up to a quarter of women suffering from l ow libido, flibanserin is expected to be as popular as Viagra, a drug used to treat erectile dysfunction in men which has worldwide sales totalling more than £2billion a year.
Its success has helped to transform US firm Pfizer into one of the world’s biggest pharmaceuticals companies.
Cindy Whitehead, chief executive officer of Sprout Pharmaceuticals , said recently: ‘We are one step closer to bringing to market the first treatment option for the most common form of female sexual dysfunction.’
‘First treatment for women’