It's been a big week for Sprout Pharmaceuticals with the FDA approval of Flibanserin, the first drug to treat female sexual desire disorder and a $1bn acquisition by Canadian drug company Valeant Pharmaceuticals, which was announced 36 hours after the drug was approved.
Flibanserin (trade name Addyi) has been around for a while and well studied but failed approval in 2010 and 2013 because of concerns over its effectiveness and side effects, which include nausea, dizziness, fatigue and fainting. I first came across it when I was researching my Orgasm book in 2006 when the original makers Boehringer Ingelheim did tests and found it boosted libido for women as an anti-depressant.
It was being described by the press as a 'pink pill' or 'female Viagra' - an unhelpful comparison as it doesn't work in the same way as Viagra, which increases blood flow to the penis to help with erectile dysfunction. Instead it targets neurotransmitters in the brain - serotonin and dopamine - to make you feel sexy and relaxed.
Like Viagra, which was created by Pfizer to treat men with high blood pressure before researchers realised they weren't giving the pills back and did some further investigation, its development as a 'sex drug' was accidental. Addyi was initially conceived as an anti-depressant, but researchers discovered positive effects on libido in women. Addyi is aimed at a specific subset: premenopausal women with Female Sexual Interest/Arousal Disorder (FSIAD), which according to statistics affects one in 10 women.
Inevitably there's been lots of celebrating at Sprout and pressure groups like Even the Score (a coalition of 24 women's health groups backed by Sprout) who have been lobbying the FDA since the 2013 rejection asking why there is nothing for women. Sally Greenberg, Executive Director of the National Consumers League says "it's the biggest breakthrough for women's sexual health since the pill." A controversial move but one I've been expecting for a while given that men have had numerous options since Viagra was approved in 1998 to help with erectile dysfunction. There are over 20 drugs for men for sexual dysfunction and until now women have had nothing.
I can't see this flying off the shelves like Viagra however. It has to be taken daily at night and you can't drive or operate machinery for six hours afterwards. You can't drink alcohol with it so bang goes that relaxing glass of red. It may also take up to a month to see the effects. So far, clinical trials have been moderately successful in increasing desire and satisfying sexual encounters (9% more women than placebo or from two to three satisfying sexual encounters per month). However, it's clearly had a positive effect on other women otherwise it wouldn't have been approved.
How do we gauge a drug's effectiveness in treating female libido? We can't measure units of desire so it's very much down to personal experience and success is anecdotal. Low sex drive is only a problem if a man or woman deem it is affecting their quality of life and relationship and that has been the case for women who have taken part in the trials and found it helpful. I've read comments like "I want to want my husband. It's as simple as that."
It also needs to be prescribed by a physician (who may have concerns over side effects) and is costly (an estimated $400 per month which will rule out low income women) so it may become a lifestyle choice unless it is covered in part by insurers (who will face pressure to do so as they have insured Viagra). Women will only want to pay a monthly fee for it if it is helping them significantly.
In terms of the medical profession taking female sexuality and women's health seriously it's a good move although I have concerns about the side effects and am curious to know how effective it really is. It will be interesting to come back to this in a year's time and see what women have to say about it and its success also depends on whether Valeant can get it out into the world through European licensing and speaking to GPs who will be prescribing it. They say it will take $20m sales to break even on their acquisition of Sprout so time will tell.
I have some questions for Cindy so have asked for a follow-up Q&A - it's being targeted at women but does it work for both sexes given that it affects brain chemistry? Couples may end up taking it together so how will they ensure it doesn't become a lifestyle drug? They say they won't be advertising to consumers through normal channels for the first 18 months after its release and will focus their marketing efforts on doctors.
Is it safe to use with the contraceptive pill? What herbal medicines are contraindicated? And why are they aiming it at premenopausal women (40-50) and not postmenopausal women (50+) for whom it may be more useful? I presume they will target that subset in the future.
I'd also love to hear her thoughts on female empowerment as this drug has become politicised, about the struggle in getting it to market and what other women's health issues they would like to tackle, as this is clearly a gateway drug that paves the way for other sexual dysfunction drugs (one currently in development by Palatin Technologies) and for further research into sexual health.
I had an email from the Central and North West London NHS Trust in response to the news saying that lack of interest in sex is a major reason for referral to sex psychologists and centres but that sexual response is far more complicated than popping a pill and so this isn't a panacea for all.
"Sexual desire is, of course, mediated by biochemical mechanisms such as sex hormones and neurotransmitters, but it is also affected by our sexual partners, how we feel about our bodies and the relationship we have developed with sex over the years," says Dr Karen Gurney, CNWL Sexual Problems Assessment and Treatment Service Lead.
"In our clinic we very rarely find a physical reason to explain lack of desire, and we often find that on further questioning a flicker of desire is present, but that having the time or energy to nurture it, having different ideas about it than a partner, struggling to communicate about it or feeling bad about it are often the factors which stop it turning into something more. These are not factors that a pill can change, sadly. The irony is we find we can make huge progress with couples in addressing issues of low sexual desire in only a few sessions of psychosexual therapy to great effect, without the need for long term medication.
Of course medication isn't the answer to everything and it's not valid as a long term choice - it is just one option as part of the journey, but if its existence encourages women to speak to their GP about their sexuality and kickstarts something that has been dormant for years causing distress then that's a positive thing. Why should there be over 20 drugs for men with sexual dysfunction and nothing for women? It needs to be prescribed safely and on a trial basis in conjunction with sex therapy and bodywork sessions for those who want it in a holistic approach to female sexuality.
Addyi will be available from October 17th on prescription in the US. It's not clear if it will be licensed for use in Europe.
This post was originally published on Rude Magazine.
Photo: Sprout Pharmaceuticals