Ladies – upto half a satisfying sexual event per month but risk of side effects from “Pink Viagra” Flibanserin (“Addyi”)

Ladies – upto half a satisfying sexual event per month but risk of side effects from “Pink Viagra” Flibanserin (“Addyi”) Yesterday (29th February 2016) the JAMA Internal Medicine journal published the results of analysis of Flibanserin (sold as ‘Addyi‘ and sometimes referred to as the “Pink Viagra“) to treat Hypoactive Sexual Desire in Women. The improvement in Satisfying Sexual Events (SEEs) was quantified (see below) as was the nature and risks from side effects.

The developers of the “female libido pill” Flibanserin (marketed under the name Addyi) have clearly demonstrated commitment to their product having had it rejected twice by the US Food and Drug Administration (FDA). Flibanserin started life as an antidepressant but following its failure in that application found a new lease of life as a potential treatment for hypoactive sexual desire disorder (HSDD) in pre-menopausal women. This is defined as a sexual dysfunction characterized as a lack or absence of sexual fantasies and a lack of desire for sexual activity (as judged by a medical professional).

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In the FDA’s first evaluation of this drug for improving sexual desire in women (2009) the clinical reviewers and an external advisory committee voted unanimously (11-0) against approving Flibanserin. They concluded that its uncertain benefit did not outweigh its harms. In 2013, after Sprout Pharmaceuticals had acquired the rights to the drug, it was resubmitted to the FDA with a new efficacy (ability to produce the desired effect) trial and interaction studies. For this submission the drug’s interaction with alcohol was tested – interestingly on men rather than the target population of pre-menopausal women. The combination of the two drugs led to an increase in hypo-tension (low blood pressure). Other tests, this time with women, in combination with certain medications (fluconazole, a CYP3A4 inhibitor used to treat candida in ‘Yeast infections‘) also led to hypo-tension. The FDA rejected flibanserin a second time concluding that the small treatment differences (sexual desire benefits) did not clearly outweigh safety concerns. An appeal by Sprout was unsuccessful.

Model of Fluconazole used to treat Yeast Infections

Prior to its third submission to the FDA Sprout supported the launch of an advocacy group ‘Even The Score‘ which conducted an intense promotional campaign towards journalists, women’s groups, congress and the FDA. The advocacy group campaign emphasized that although there were several approved treatments for male sexual dysfunction, no such treatment for women was then available. From their website: “Even the Score: A campaign for women’s sexual health equity was created to serve as a voice for American women who believe that it’s time to level the playing field when it comes to the treatment of women’s sexual dysfunction” – link here.

The third submission to the FDA occurred in 2015 and although it did not include new information about the efficacy of the drug it did have some reassuring information about the potential of the drug to cause somnolence (sleepiness or drowsiness) when driving. Unfortunately other information submitted did heighten concerns relating to dangerous interactions with other drugs.

With regard to this submission there was some dissent within the FDA. Its own clinical reviewers still recommended rejection: “We do not believe that it is reasonable for the approximately 90% of treated patients who will not respond to the product to be exposed to the numerous serious risks posed by flibanserin therapy.” They were overruled by two FDA directors who, while acknowledging the limited efficacy and worrisome harms of the drug, emphasized that it met a need in women for whom other (sexual desire) treatments had failed. The drug was approved but the FDA required that it has a black box label, their most serious safety alert, reflecting problems associated with the drug. Clearly the advocacy group’s message had reached its target.

Upon getting FDA approval flibanserin was sold to Valeant Pharmaceuticals for around $1 billion.

The new report in the JAMA Internal Medicine journal involved a systematic review and meta analysis of 8 previous studies into the efficacy and safety of flibanserin for the treatment of Hypo Sexual Desire Disorder. Nearly 6000 women were involved. The treatment resulted on average in one half of a satisfying sexual experience per woman per month compared with placebos (non-effective pills without any active ingredient). Against this benefit a significant increased risk of dizziness, somnolence, nausea and fatigue was identified. The authors of the paper (Jaspers et al) concluded that the modest sexual desire benefits of the drug did not outweigh its harms. In addition to the negative effects mentioned above was the risk of hypo-tension and syncope (fainting/passing out caused by reduced flow of blood to the brain) when combining flibanserin with alcohol and some other common drugs.

The authors recommended more research including women from diverse populations e.g. those with co-morbidities (additional disorders or diseases), those using other medication and those having undergone surgical menopause. The original papers reporting this work can be found using the links here and here.

If in doubt always check with your medical doctor.

Chris Duggleby

Hypoactive Sexual Desire? Why not try my African Tribal Fertility Dance? According to the Pretty Spandex Boys it can improve the sexual desire of both genders:

Black Pudding Breakfast - a Scottish approach to dealing with sexual dysfunction - sometimes known as the "morning after pill". Apparently it works on both sexes. — Black Pudding Breakfast – a Scottish approach to dealing with sexual dysfunction – sometimes known as the “morning after pill”. Apparently it also works on both sexes.

Chris Duggleby started his scientific career studying Bacteriology, Virology and Immunology at the Manchester University Medical School. From there he went on to spend over 35 in the chemicals and oil industries which included setting up a polymers research and development group in Geneva, Switzerland for a major international chemicals company. Following an MBA from Warwick University he went on to lead a number of international manufacturing and marketing operations in the Chemicals, Plastics and Oil industries. This included being the founding President of Formosa BP Chemicals Corporation in Asia. His work involved living and working in Europe, Asia, the USA, the Middle East, and Russia. More recently he was invited to take on a senior leadership position in the Audit Department of the BP International Oil Group. Here he used his global change and risk management experience to help the group reshape its management structures and processes following a major environmental disaster in the Gulf of Mexico. He has now retired to focus on writing about risk management and producing music in his studios near London, in the Alps and Cape Town. If you are interested in risk management check out his RiskTuition.com or BizChangers.com (management of change) sites. He has also recently launched the JointVentureRisk.com site.

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