A new drug for low sexual desire in women: Bremelanotide

Women who feel distressed by a lack of sexual desire may have some help on the way. Recently the FDA approved bremelanotide (Vyleesi), a new medication for premenopausal women with hypoactive sexual desire disorder (HSDD). HSDD is a term coined to describe low sexual desire without a clear cause. So, women who might like to try this new drug need to know that it is not intended to help in situations where desire diminishes due to

• a medical or psychiatric illness
• interpersonal or relationship problems
• side effects from another treatment or medication.

What does research tell us?

The physiology of sexual arousal and desire is complex in women. Yet there’s not a lot of research in this area. An estimated 40% of women are affected by a lack of desire for sex. The numbers vary depending on what age women are, where they live, and whether they have recently given birth, but there’s no doubt that it is a significant problem for some women.

In research funded by a licensing partner of the drug manufacturer, bremelanotide was studied for both effectiveness and safety. According to information released by the FDA, more than 1,200 women randomly received either bremelanotide or a placebo (sham treatment) for up to 24 weeks.

About 25% of the women who took bremelanotide reported some increase in sexual desire compared with 17% of those who took a placebo. The research also looked at the women’s distress over low sexual desire. About 35% of the patients treated with bremelanotide experienced some improvement in their distress compared with 31% of those who took a placebo. However, bremelanotide did not change or improve the number of satisfying sexual events.

How is the drug given?

At least 45 minutes before anticipated sexual activity, a woman injects the medication into a thigh or her abdomen (or her partner can do this). No one knows precisely how bremelanotide works, but it does activate melanocortin receptors, which seem to be involved in a host of brain activities, including possible links to appetite and cardiovascular health. Experts do not know how long the effect will last after each dose, so only one dose a day is recommended, and women should not take more than eight doses in a month. Additionally, those who experience no improvement in sexual desire or related distress within eight weeks should stop using the medicine.

What are the possible side effects?

As with any medication, side effects may occur. The most common ones are nausea and vomiting, experienced by about 40% of participants in the studies. Nausea is more likely the first time the medication is used, and becomes less of an issue with subsequent doses. Still, as many as 13% of those who felt nauseated actually needed some treatment for their nausea. Other possible side effects include flushing and headache.

What else should I know?

Bremelanotide is approved for use only if a woman’s sexual desire has diminished — not if a woman has always had struggles with sexual desire. Also, bremelanotide is for generalized HSDD, which means decreased sexual desire regardless of the kind of sexual activity involved (including masturbation), the environment, or who the partner might be.

More research is needed on side effects. There are also some safety precautions. Women with high blood pressure should avoid bremelanotide because it can temporarily raise blood pressure. Nor is it recommended for women at risk for cardiovascular disease. Women who use naltrexone to treat alcohol dependence should not use bremelanotide because of drug interactions. Also, some women in the studies experienced darkening of skin and gums. Although rare, such changes are permanent.

The bottom line

For women, low sexual desire and distress linked with it are complex and challenging to treat. It’s encouraging that the FDA has identified female sexual dysfunction as one of 20 disease areas that deserve attention. Bremelanotide modestly increases sexual desire in some women, and may slightly lessen distress over a lack of desire. While current research suggests it doesn’t improve sexual satisfaction or affect how often a woman engages in sex, the availability of this potentially helpful medication could be a step in the right direction for some women.