Is Addyi the New Female Viagra?

Molecular structure of flibanserin (Addyi, female viagra)

There is no doubt that there is a need for a female version of ‘Viagra’ with one in 10 women in the US lacking sexual desire to an extent that it impacts their quality of life.  With this in mind good news came through in August 2015 when the FDA approved the drug Flibanserin (Addyi®) for hypoactive sexual desire disorder in pre-menopausal women.

It has been a long road for Addyi to come to fruition. Originally developed as an antidepressant it was soon found to have a secondary beneficial effect of increasing satisfying sexual events (SSE’s) for women. Like many other pharmaceutical compounds before, the original development was set aside and the new, more lucrative development pushed forward.  It was however met with a stumbling block in 2010 when Flibanserin received a negative evaluation from the US Food and Drug administration.  Boehringer Ingelheim ditched the drug and Flibanserin was left on the shelf until Sprout Pharmaceuticals took up the challenge again.

It would be fair to say that Sprout Pharmaceuticals used all its might to have the drug approved.  This included launching the campaign and subsequent website ‘Even the Score‘. The website generated publicity for female sexual dysfunction and questioned the FDA and political leaders as to why there is such a disparity between male and female treatment options (26 to nil in fact). In turn the FDA held a two day public meeting on female sexual dysfunction and a letter from US congress was sent to the FDA imploring them to see female sexual dysfunction as ‘one of 20 key unmet medical needs in the US’.

So August 2015 saw Flibanserin approved for hypoactive sexual desire disorder for pre-menopausal women. However restrictions on prescribing Flibanserin and boxed warnings were imposed by the FDA due to the increased risk of severely low blood pressure and fainting when Flibanserin and alcohol are combined. The restrictions require both prescribers and pharmacist to enrol and complete training on flibanserin before prescribing and dispensing Addyi. Sprout Pharmaceuticals say they are ‘committed to breakthrough firsts in women’s sexual health’ which is just as well as the FDA also requires the company to conduct three studies in women to better understand the interaction between Flibanserin and alcohol.

Finally female sexual dysfunction is getting the attention that is rightly deserves, but this drug is not Viagra for women. Female arousal is complicated involving neurotransmitters, sex hormones (testosterone) and other hormones. While Viagra directly increases blood flow to the penis to cause an erection, Flibanserin looks to alter the neurotransmitters within the brain involved in sexual excitation. In the Flibanserin clinical trials, satisfying sexual events (SSEs) increased from 2.8 per month to 4.5 per month in pre-menopausal women with hypoactive sexual desire disorder, however the placebo group also saw an increase from 2.7 to 3.7 SSE’s per month. Overall there was about a 10% increase in meaningful improvements in SSE’s, sexual desire or distress. This is in contrast to Viagra which is somewhere between 30% to 80% effective depending on circumstance and the source of information.

In any case this is a step in the right direction to finding more treatments for female sexual dysfunction. Sprout Pharmaceuticals must be on to something worthwhile with the announcement that the company was sold for one billion dollars the day after Addyi was approved. The challenge now lies in discovering and approving more safer treatments for female sexual desire disorders.

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