Its promise to lift flagging libidos raised hopes among women around the world. But flibanserin, the first ‘female Viagra’, may turn out to be a bit of a flop.
Health regulators deciding whether to give the ‘pink Viagra’ the green light have given it a lukewarm reception. Drug reviewers at the U.S.’s Food and Drug Administration, said that it had failed to make the grade in two studies designed to gauge its effectiveness.
Rather than making a ‘significant’ impact on libido, flibanserin only made sexual encounters ‘slightly’ more satisfying.
The aphrodisiac is also far from side-effect free. Problems with the range from the unfortunate, such as drowsiness, to the unpleasant, including depression, fainting and dizziness.
Tolerability of the drug is ‘moderate’, the FDA staff said, adding, ‘it is not clear if labelling alone will be sufficient to alert women to the numerous drug interactions that exist with flibanserin’.
It also takes several weeks for the drug’s effect to build up, meaning it cannot simply be ‘popped’ on demand.
An FDA advisory committee of outside experts will meet on Friday to consider whether to recommend approval for flibanserin.
The agency is not required to follow the advice, but often does. Presented with the same data, European regulators may come to a similar decision.
Failure to give it a licence would be a bitter disappointment to its German manufacturers, Boehringer Ingelheim, who were predicted to make more than £2billion a year in worldwide sales, as well as the millions of women whose sex life has lots its sizzle.
Even if it is approved for use in Europe, it is unlikely to be widely prescribed by a Health Service struggling to find cash to fund treatment of life-threatening illnesses.
NHS prescriptions for Viagra are mainly limited to men with pre-existing medical conditions such as diabetes and prostate cancer.
Since the launch of Viagra in 1998, drug companies have tried to create a host of pills, potions and patches designed to satisfy women’s needs but none have been a success.
Some doctors are also sceptical about the need for pills to boost female sex drive and have accused drug companies of creating a market for new medications.
They point out that a pill is not going to fix a broken relationship or help ease the burden of childcare or housework.
Dr Elizabeth Kavaler, a urologist at Lenox Hill Hospital in New York, said: ‘It’s a fairly complicated area, unlike in men’s sexual dysfunction where there’s a major mechanical concern.
‘In women there’s no mechanical concern, so if she’s not having a successful sex life, where is the problem?’
