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Ten Things You Need to Know Before Flibanserin Gets FDA Approval on 18 August

15/06/2015 08:28 BST | Updated 15/06/2016 10:59 BST

1. There are 26 approved drugs licensed to treat various sexual dysfunctions for men.

2. There are, as yet, ZERO approved drugs to treat female sexual dysfunction.

3. Hypoactive sexual desire disorder (HSDD) is the most common form of sexual dysfunction in women. It affects one in ten women and is defined as a persistent and distressing biological lack of desire for sex. HSDD is a specific and diagnosable condition, but many more women lose their sexual desire as a result of situational, relational, psychological, medical or hormonal flux.

4. Flibanserin, a drug designed to treat HSDD, has twice been rejected by the US Food and Drug Administration (FDA), because it's side effects, which include dizziness, sleepiness, and nausea, were considered to outweigh the benefits.

5. However, last week, an advisory committee to the FDA voted 18 to six that the drug Flibanserin should be approved for the treatment of HSDD in women. The approval date is set for August 18th.

6. Flibanserin has already been the subject of a large scale multi-centre clinical trial involving more than 5,000 pre-menopausal women with generalized acquired HSDD. In the study, women receiving Flibanserin reported that the average number of times they had a "satisfying sexual event" rose from 2.8 to 4.5 times a month.

7. It was an encouraging result, but it was not conclusive because in the same study, women who were receiving a placebo drug also reported an increase in "satisfying sexual events". Their sexual frequency went from 2.7 to 3.7 times a month.

8. Women with HSDD are unlikely to care whether an improvement in their condition is brought about by a drug, or by placebo priming, but the FDA advisory panel is anxious about women who don't have HSDD using Flibanserin. It has long been known that male erectile function drugs are used recreationally, but, for example Viagra and Cialis are taken once and they then work for a set period of time and disappear from the system. Flibanserin needs to be taken daily, so those nasty side effects should be enough to dissuade any woman who isn't desperate.

9. It is difficult to interpret the previous decisions not to licence Fliberansin as anything other than sexist and the campaign group 'Even The Score' has worked hard to ensure that this FDA submission goes through. As they point out, most drugs have side effects and women are perfectly capable of making up their own minds about whether or not they are willing to endure them in exchange for an increase in their sexual desire, and an improvement in their sexual relationships.

10. Female sexual desire is undeniably complex, but the existence of an approved treatment will at least allow women to feel that they have an option, and post approval, the expected tsunami of associated advertising will help to raise awareness about female sexual health in general and female sexual dysfunction in particular.