On Friday, the FDA approved a new drug meant to boost female libido, only the second of its kind to enter the market. Vyleesi, which is being touted as “female Viagra,” claims to be the answer that women with low libido have been waiting for, but it hasn’t come without controversy.
Vyleesi, whose generic name is bremelanotide, follows the 2015 launch of the drug Addyi, a daily pill meant to treat hypoactive low sexual desire disorder (HSDD) in premenopausal women. While Vyleesi is also approved to treat HSDD, it differs from Addyi because it comes in the form of an injectable rather than a pill and is only to be used before sex rather than on a daily basis. (Vyleesi is set to become available in September, and the drugmaker has not yet determined pricing or reimbursement information.)
Women with HSDD have low sexual desire not caused by a medical or mental health problem or by a problem in their relationship. Stephen Snyder, MD, associate clinical professor of psychiatry at the Icahn School of Medicine at Mount Sinai and author of Love Worth Making: How to Have Ridiculously Great Sex in a Long-Lasting Relationship, previously told Health that women with this condition love their partners and want to experience more sexual desire, but for some reason have lost their once-healthy libido.
When injected into the thigh or abdomen at least 45 minutes before sex, Vyleesi reportedly activates receptors for a group of hormones called melanocortins, which have been associated with sexual arousal and appetite. But "the mechanism by which it improves sexual desire and related distress is unknown," according to a press release by the FDA.
(It’s important to note that although Vyleesi is being called “female Viagra,” erectile dysfunction medications like Viagra, or sildenafil as it's known generically, work by dilating the blood vessels that provide blood flow to the penis—a very different mechanism.)
But, before you get your hopes up, you should know that the results from the clinical trials were less than impressive. About 25% of patients who took Vyleesi reported an increase in their sexual desire. That’s just slightly more than the 17% of patients who took a placebo and reported the same. What’s more, 40% of patients experienced nausea after taking it, and 18% of women dropped out of the trial, including 8% who stopped because of nausea. (Addyi’s clinical trial results weren’t much better, and it also has some concerning side effects.)
About 1% percent of the patients who took Vyleesi for the trials also reported darkening in their gums and parts of their skin, which didn’t go away in about half of the patients after they stopped treatment. Another downfall: Patients aren’t advised to use Vyleesi more than once within 24 hours or more than eight times per month, which could be limiting if a patient wants to have sex more frequently.
The FDA also said that people with high blood pressure or who have cardiovascular disease, or those at high risk for cardiovascular disease, shouldn’t take the drug. Sick of the caveats? Us too.
Some argue that drugs like Vyleesi are finally leveling the playing field for women, as men have had ED medications for decades. But others say these drugs are just a pharmaceutical solution for something that actually goes much deeper. To say that any drug is a surefire way to kick a woman’s libido into high gear would be to completely ignore the emotional aspect of arousal. Of course, everyone is different, but for many women, intimacy and emotional security are the keys needed to rev the engine of sexual desire.
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