What is “female viagra”? Five things you should know about the world’s first pill for women’s sex drive
Yesterday, the first ever medicine to improve women's sex drive won final approval from the Food and Drug Administration (FDA).
Called Flibanserin, or Addyi, it is owned by a private US company called Sprout Pharmaceuticals, and will be sold by pharmacists across the US from October this year.
The pink pill aims to enhance libido in women suffering sexual dysfunction, and is the only treatment of its kind to have made it this far in the approvals process. Doctors in the US have dubbed it the “female viagra”.
But while its introduction to the US is pleasing to many, it hasn't come without controversy – there is wide scepticism about its effectiveness, and some believe it was only approved because of pressure from women's groups.
So, what is Flibanserin exactly, and why has it caused such a fuss? Here are five things you should know about the new drug.
It used to be an antidepressant
Flibanserin was first created as an antidepressant in the 1990s by German pharmaceutical group Boehinger Ingelham.
When it went through trials, it didn't do much to rid people of depression, but it did have an unexpected effect – it increased sex drive in some of the female volunteers. At this point, the company decided to change focus entirely.
But then Sprout Pharmaceuticals came on board
Until two years ago, the pill remained in the hands of Boehinger Ingelham, but wasn't making much progress.
Sprout Pharmaceuticals, which bought the rights for the drug two years ago, was set up by husband and wife Robert and Cindy Whitehead for the sole purpose of getting it approved for use in the US.
It hit a brick wall – twice
Flibanserin has been taken to the FDA for approval two times before, and in both cases it was rejected.
On the first attempt in 2009, the drugs agency said it had too many concerns about safety, while on the second attempt in 2013 it did not find the pill was effective enough to warrant approval.
There have been no new efficacy trials since then, which has led some to question why the FDA has changed its mind.
There's scepticism about its effectiveness
The FDA's previous analysis of the drug showed that between eight and 13 per cent of those who took it experienced an in improvement in sex drive.
This amounts to an average of 0.5 more “sexually satisfying events” each months, and some believe (as the FDA did when it initially rejected it) that this is not enough of an increase to justify use.
The unpleasant side effects have caused concern
Around one in five of those who take Flibanserin experience one or more of the following side effects: fainting, low blood pressure, drowsiness, and dizziness.
There are also serious concerns about the effects of mixing the drug with alcohol and a number of drugs – the FDA advises women to take it dt bedtime to avoid this, but there is a risk people will not stick to the guidelines.
Flibanserin has only been approved in the US so far, and its success in positively transforming the sex lives of women across the country remains to be seen.
There are currently no medicines available in the UK or the rest of Europe to treat sexual dysfunction in women.