It's an injection called Vyleesi, and it just got FDA approval.

SHUTTERSTOCK/ANDRII ZASTROZHNOV

By Julia Guerra

The FDA recently announced its approval of a new medication for enhanced sexual desire in women. Some are saying the drug, Vyleesi, is a "female Viagra." But Vyleesi and Viagra really aren't one and the same.

Vyleesi is intended to help premenopausal women with generalized hypoactive sexual desire disorder (HSDD). HSDD is a condition "characterized by low sexual desire" that cannot be attributed to an outside cause, such as an existing medical or psychiatric condition, existing problems within the sexual relationship, or side effects of another medication, according to the FDA's announcement. In other words, HSDD is not the same as erectile dysfunction (ED). Rather, ED is defined as "trouble getting or keeping an erection that's firm enough for sex," according to the Urology Care Foundation. It can happen when blood flow in the penis is limited, as a result of stress or other emotional reasons, or as an early warning sign of another illness, such as heart disease or high blood pressure, per the foundation.

Unlike Viagra, Vyleesi works via an injection administered on the abdomen or thigh, about 45 minutes before an anticipated sexual encounter. Vyleesi should only be taken once within a 24-hour time period, and no more than eight times per month, per the FDA's announcement. Potential side effects can include "nausea and vomiting, flushing, injection site reactions and headache," according to the FDA.

The drug's approval process posted disconcerting results. Only two placebo-controlled clinical trials were performed, in which 1,247 premenopausal women with HSDD used Vyleesi two to three times per month for 24 weeks per trial, according to the FDA's announcement. The results showed that 25 percent of patients treated with Vyleesi reported an increase of 1.2 or more on a scale measuring their sexual desire from 1.2 to 6.0. However, the results showed no difference between treatment groups in the number of reported "satisfying sexual events," according to the FDA's announcement. "Vyleesi does not enhance sexual performance," the agency noted in its statement. Also important: The FDA admitted that the "mechanism by which [Vyleesi] improves sexual desire and related distress is unknown."

Translation: Vyleesi does not improve sexual performance (whereas Viagra does, for those with erectile dysfunction, at least), though it seems to improve self-reported sexual desire sometimes. But even then, the FDA apparently has no idea why Vyleesi works this way. (Related: "Female Viagra" Doesn't Work, Says Study)

The Biggest Difference Between Vyleesi and Viagra

The main difference between these two drugs boils down to sexual performance versus sexual desire. Viagra is typically used to improve the former, whereas Vyleesi is intended to enhance the latter. But there can easily be more factors causing a low sex drive than simply a lack of desire.

For example, mental health can play a role. Case in point: Nearly 21 percent of women experience major depression at some point in their life, and low libido is one of the most common red flags, according to Johns Hopkins Medicine.

"A primary symptom of depression is the inability to enjoy things you normally enjoy, like sex," said Jennifer Payne, M.D., director of the Women's Mood Disorders Center at Johns Hopkins. "People with depression also have decreased energy, feel badly about themselves and might view their partners through a negative filter, all of which impacts sex drive."

Women who struggle with compartmentalizing their thoughts and allowing themselves to be in and enjoy the present moment can also experience low libido, according to a study performed by researchers at the University of British Columbia. Mindfulness seems to be a key solution; even just three 90-minute sessions of a mindful meditation practice can help you stay focused and tap into your body's sensations, the researchers discovered. (Here's why your lack of sex drive isn't a disorder.)

Bottom line: Sexual desire is extremely multifaceted and complicated. Vyleesi might be a way to improve your sex drive, but the current research seems limited at best.

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