In August 2015, Sprout Pharmaceuticals received FDA approval for ADDYI™, known generically as Flibanserin. It is a once-daily, non-hormonal pill. The FDA had twice previously declined to approve this pill, repeatedly requesting further studies.
The pill will be used for the treatment of the most common form of sexual dysfunction in premenopausal women, generalized acquired hypoactive (low) sexual desire disorder (HSDD). It is estimated that 8 to 14 percent of women ages 20 to 49 have the condition, which is about 5.5 to 8.6 million U.S. women.
Low libido is a commonly known term. HSDD (Hypoactive Sexual Desire Disorder) was a new one for me, so I reached out to two doctors to get the scoop in layperson speak.
Dr. Michael Krychman*, the Executive Director of the Southern California Center for Sexual Health and Survivorship Medicine Inc. in Newport Beach CA. explained HSDD this way, “Distressing lowered sexual interest- loss of sexual thoughts, fantasies or general interest in the pursuit of sex. Many women report a loss of a sexual interest – something they definitely miss, a loss of something internal or sensual femininity. It’s lost and they want it back!”
So you’re saying we finally got our “pink pill”!!???
Dr. Josh Trutt*, a healthy aging expert at Evolved Science in New York City, adds, “Because of the frequent comparisons to Viagra, it’s worth noting that HSDD is not really analogous to erectile dysfunction. Viagra treats cases of erectile dysfunction that are primarily caused by a vascular (blood flow) problem. It improves blood flow to the penis, enabling erections, but it does not improve “desire.” HSDD is a problem of diminished desire, and Flibanserin is intended to restore that person’s diminished desire to their prior baseline.”
Ok, so calling Flibanserin our “pink pill” is misleading. This pill works on modulating key brain chemicals to restore a balance between inhibition and excitation. In contrast, as Trutt explained, Viagra doesn’t address libido. It doesn’t work on your brain, but rather on your blood vessels. Flibanserin is not indicated to enhance sexual performance.
Many women complain about a loss of libido. So, I asked Dr. Trutt how a woman would know if she was a candidate for this new pill. He said, “Anyone can have temporarily diminished libido due to life circumstances, or prolonged diminished libido due to medications, drug use, an abusive relationship, and other causes. The HSDD diagnosis tries to separate those situations out by specifying that, even within the context of the person’s age and culture, she is dealing with diminished desire lasting more than six months which is causing significant personal/ relationship distress, in the context of a stable/ healthy relationship, and these symptoms are not explained by medications, drug use or some other disease process.”
Sometimes dry vagina and loss of libido go hand in hand. It is important to note that Flibanserin is not a treatment for vaginal dryness. If a woman has a healthy libido and yet is nevertheless not lubricating adequately, that issue needs to be addressed separately with your healthcare provider.
Dr. Krychman stressed the importance of speaking with your health care professional. He further added that the DSDS (decreased sexual desire screener) can help with the diagnosis. HSDD may be caused by other conditions, psychiatric/medical or psychological or even a destructive relationship- these issues are not HSDD.
I was curious as to why this is approved for premenopausal women only. Dr. Krychman, responded, “Right now it has been studied in over 11,000 women (both pre and post-menopausal). However, the drug is FDA approved for premenopausal women, only. The drug has been studied in both populations and has been shown to be effective and safe. Providers may choose to use this medication in women over 50 who have HSDD, however, it would be considered off-label use!”
Doctors must rule out many issues before diagnosing the condition such as; relationship issues, medical problems, depression and mood disorders. I wondered if there are similar requirements on doctors before they prescribe Viagra, Cialis and other drugs used to treat erectile dysfunction. Dr. Krychman explained, “Not really- but good sexual medicine physicians will look at the balance of both medical and psychological causes of sexual problems and rule in or out confounding issues and treat or offer interventions accordingly.”
According to Even the Score (an advocacy group sponsored by Sprout Pharmaceutical), the FDA has been exhibiting gender bias in approving 26 medicines for sexually-related disorders in men and zero or few for women.
There is still plenty of controversy over this drug. Flibanserin regulates two neurotransmitters — dopamine and serotonin – brain imagining studies of women with and without HSDD implicate the brain’s frontal cortex, which many think control hormones related to sexual desire. However, there are many skeptical physicians who aren’t sure what role these neurotransmitters actually play in causing HSDD. Some say it is not actually clear as to how the drug actually boosts libido in women who are helped by the drug.
Dr. Trutt commented, “There has been a lot of talk about the FDA being biased against women, such that Flibanserin is the first approved drug to treat women with low sex drive. But it seems to me that this may be a bit misleading: there are no FDA-approved drugs for men with low sex drive either. Viagra does not treat low sex drive; it treats a physical inability to perform.
In that sense, Viagra is more similar to Premarin or Vagifem, which have been approved for vaginal dryness– and Premarin was FDA-approved for that purpose many years before Viagra came along! Testosterone has been used off-label for low libido in men, but that is not an FDA-approved use. (Testosterone is FDA-approved specifically for the treatment of low testosterone levels combined with an associated medical condition. If a man has low libido but normal testosterone levels, testosterone is not FDA-approved for the treatment of his low libido.)
Trutt went on to say, “It is very common for libido to decrease around menopause, when testosterone levels drop. Many studies have definitively shown the benefit of testosterone on women’s libido and sexual response. A 2014 review paper on the use of testosterone for women with HSDD stated:
“On the basis of our analysis of 20 randomized, placebo-controlled trials, we can conclude that testosterone has a positive effect on sexual response [in women], having been reported to increase pleasure from masturbation, sexual desire, the frequency of sexual activity, sexual satisfaction, and orgasm. These findings are consistent with those of other studies showing increases in sexual desire, the frequency of sexual activity, and sexual satisfaction in women receiving androgen therapy.”
Trutt further explained, “Testosterone improves libido in women– and testosterone has been available for women for decades. Estratest came on the market in 1964 and was originally marketed for hot flashes, but has been used off-label for low libido since at least 2003. While Estratest was not FDA-approved for low libido, it is available (and so is compounded testosterone), so the fault probably does not lie with the FDA so much as with our doctors, who have been reluctant to prescribe testosterone for women. Many of my patients see dramatic improvements in libido when their testosterone is replaced. Given the added benefits of preventing the muscle loss (sarcopenia) of aging, and improved bone density, certainly in my practice I would check testosterone levels before turning to a medication that affects dopamine and serotonin receptors.”
As in most medications, there is a big list of contraindications with Flibanserin. One that particularly stood out for me was: alcohol. These FDA’s concerns over Flibanserin’s side effects may still restrict the number of doctors and pharmacists who are willing to offer it to patients. Common side effects of Flibanserin include dizziness and sleepiness. A few patients who took a too-high dose or consumed alcohol with the medicine in clinical trials also experienced a drop in blood pressure that caused them to faint.
We often joke about low libido, but for many women HSDD is a serious condition. It is up to you and your healthcare professional to determine which protocol is best for your personal health needs. Staying on top of the latest information will help you be your own “best” healthcare advocate.
My Motto: Suffering in silence is OUT! Reaching out is IN!
Click here to download my free eBook, MENOPAUSE MONDAYS The Girlfriend’s Guide To Surviving and Thriving During Perimenopause and Menopause.
Dr. Krychman reports: Consultant/Advisory Board: Palatin, Pfizer, Shionogi, Sprout, Noven, Viveve Medical Materna.
Dr. Trutt reports: none