Some women will soon have a new option to boost their sex drive.
In June 2019, the U.S. Food and Drug Administration (FDA) approved Vyleesi (bremelanotide) — an injection designed to improve libido in premenopausal women.
Vyleesi is intended to treat women with hypoactive sexual desire disorder (HSDD) that causes significant distress but isn’t due to a medical problem, medications, or issues in a relationship.
Hypoactive Sexual Desire Disorder (HSDD) Is a Very Real Problem
Ten percent means “that if I do 10 exams in one day, one of those women will have a low libido issue that causes distress,” says Becky Kaufman Lynn, MD, the director of the Center for Sexual Health at Saint Louis University in St. Louis. “So it’s a really big problem. I see, every day, how much low libido affects relationships and how much it affects women.”
With Vyleesi hitting the market this fall, here are six things you need to know about the new drug.
1. Vyleesi Is Not Female Viagra
While some media outlets tout Vyleesi as the “female version of Viagra,” the new medicine works in a completely different way from the little blue pill.
Viagra works on the mechanics of sex by dilating the blood vessels that provide blood flow to the penis. Although the mechanism by which Vylessi works is not clear, it is thought to alter the pathways that contribute to sex drive and arousal.
“Viagra works on the penis, but Vyleesi works in the brain,” says Dr. Lynn.
It’s also important to note that female HSDD is an extremely complex condition that’s characterized by a lack of interest in sex, which may be caused by a variety of factors. Men with erectile dysfunction don’t necessarily have low libido issues; they may simply have a problem with blood flow that can be corrected with the right treatment.
2. Vyleesi Is Different From What’s Currently Available
Vyleesi is only the second drug approved to treat HSDD. It comes as an injection that women administer at home in the thigh or abdomen at least 45 minutes before anticipated sexual activity.
The other medicine to treat HSDD, Addyi (flibanserin), was granted FDA approval in 2015. It is taken as a daily pill to improve sex drive.
“Vyleesi is more of an as-needed medicine, whereas Addyi is taken every day,” says Lynn.
And while Vyleesi offers a crucial new option for women, Lynn says there are also many nonpharmacological alternatives to consider for low libido.
“Depending on the situation, there are things other than pills and injections,” she says. “Maybe it’s therapy. Many women say exercise helps. I also often recommend erotic reading or listening to erotic podcasts.”
3. It Has Side Effects
Nausea is the most common side effect of Vyleesi. In fact, about 40 percent of those who took the medicine experienced nausea, with most episodes occurring after the first injection.
“The good news is Vyleesi doesn’t have to be taken daily, so women can decide if the nausea is worth it,” says Lynn. “They can say: ‘Is my low libido so bad that I’m willing to put up with this nausea?’”
Vyleesi can also cause a temporary increase in blood pressure that usually goes back to normal within 12 hours. Because of this, women with heart disease or uncontrolled high blood pressure shouldn’t take the medicine. Additionally, about 1 percent of women reported darkening of the gums and parts of the skin when taking Vyleesi. This side effect didn’t go away in about half of the cases.
“Every single medicine you prescribe is going to have risks, and it’s going to have side effects,” says Lynn.
4. It’s Been Tested in Clinical Trials
Prior to FDA approval, Vyleesi was tested in two large randomized clinical trials, involving 1,247 premenopausal women. The effectiveness of the medicine was determined by “sexual desire scores,” which were provided by the participants. Results showed about 25 percent of women treated with Vyleesi had an increase of 1.2 or higher in their sexual desire score compared with about 17 percent who took a placebo.
Around 35 percent of women who took Vyleesi had a decrease of 1.0 or more in their distress score compared with 31 percent of those on a placebo.
5. The Drug’s Cost and Availability Aren’t Known
AMAG Pharmaceuticals, the company that will market Vyleesi, estimates that the drug will become available sometime in September 2019.
The cost of Vyleesi hasn’t been released.
“I’m really hoping that it’s going to be a reasonable price that women can afford,” says Lynn.
6. Vyleesi Is Helping Level the Playing Field for Women
While men with sexual dysfunction have had medical options, such as Viagra, for more than 20 years, women haven’t been as fortunate.
“We are completely behind when it comes to helping women,” says Lynn. “And the naysayers who don’t believe that this [HSDD] is a real condition are just setting back women’s sexual needs even more.”
Some experts believe the availability of more pharmacological options, like Vyleesi, is a step in the right direction for a problem that impacts the quality of life of many women. It at least may indicate that women’s sexual health is becoming more of a priority.
“If you think about it, we have food, water, shelter, and sex. Sex is a huge part of who we are, and it’s such an important part of our life,” says Lynn. “A bad sex life can really harm a relationship, and it can really harm a woman.”
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