My 50+ Girlfriend: “The new “female Viagra” is going to be the answer!” [to her long-standing issue with low libido]
Me: “No, there’s no one single answer to this issue – it’s a problem with a lot of aspects.”
Her: “No! You’re wrong! This drug is going to fix this problem.”
We ALMOST have the first FDA-approved drug to help women with low sex drive, medically known as hypoactive sexual desire disorder (HSDD). The drug is called flibanserin, to be marketed as Addyi (how do you pronounce this? And who else besides me is going to think it sounds like the latest ADD drug?).
For restoring libido in women, I prefer to replenish natural hormones including estrogen, testosterone, and oxytocin, rather than medicalize the problem and prescribe a drug for it. In this priceless quote from an article in The Atlantic magazine in 2012, “It [another potential pharma drug for HSDD] may distract from treating the real etiologies — focusing on medication when what you really need is tango lessons.”
Nonetheless, assuming it gets approved, I will be happy to prescribe it for women who want to try it. It was tested and developed in pre-menopausal women, so no one should hold her breath for insurance approval anytime soon, especially if she is already in menopause. I’ll be learning the self-pay price once it is released.
Flibanserin works on the brain neurotransmitters serotonin and dopamine (i.e. nothing like the mechanism of Viagra). It was first developed as an anti-depressant, but it didn’t work very well for that purpose. Its potential to help women’s sexual desire was first discovered in 2006, and here we are in 2015.
This is not unusual – Viagra took over12 years from initial idea (as blood pressure medication) to license as a drug for erectile dysfunction. However, when Viagra applied for approval, it only took about a year. Flibanserin has been trying for over 5 years.
When it comes to pharmaceutical drugs (and with most other things in life), it is about risks vs. benefits; which is greater for you as an individual – the benefit from it or the side effects. As with most other drugs that affect brain chemistry, side effects were “mild to moderate” and included dizziness, anxiety, fatigue, dry mouth, nausea, insomnia.
Arguments continue over how much benefit it had. For example, in the third (the most recent) large, randomized, controlled trial, women taking flibanserin went from reporting 2.5 “sexually satisfying events” per month to 5.0 such events. The women in the placebo group went from 2.7 up to 3.5 such events.
Many of you know my riffing on what can be done with statistical analysis, i.e. that you can “prove” almost any point with the same set of numbers. Here is the best conclusion I have read so far: it is up to a woman and her doctor to say how significant this improvement is for her. I think even a small change could mean the difference between a couple staying together or not.
The latest is this: an FDA panel of advising doctors met in June and recommended 18 to 6 that the FDA approve flibanserin. The FDA is not required to follow the advice of its own appointed panels, but it usually does. It will make a decision very soon – by Tuesday August 18th.
Meanwhile, I’ll keep evaluating and treating the underlying hormonal imbalance causes of the complicated issue of low sex drive in women.
[Post-script: in what I actually think is a great step, on August 18th, 2015, the FDA approved this drug to help Pre-menopausal women with low libido. Like I said, one more tool in the toolbox.]