FDA Approves Vyleesi for Female Sexual Arousal Disorder, Which Is Not a Female Viagra

Vyleesi is a medicine that contains bremelanotide, a drug that is used to treat low sexual desire in women.

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After the approval of blockbuster drug Viagra for treating erectile dysfunction, drug companies are trying to develop a drug that can help women with sexual dysfunction. For years, Viagra helped millions of men, but pharma companies failed to develop a medication for women with sexual arousal disorder.

There is a drug available for women with low sexual desire, which is called Addyi (flibanserin). It is considered a “Pink Viagra” or “Female Viagra.” However, for some reason, it helped only a few women with female sexual arousal disorder (FSAD).

Unfortunately, Addyi did not meet the expectation of most women. It did not match the extremely strong supremacy of Viagra. The drug comes with certain limitations; for instance, it cannot be taken with alcohol and it has to be taken on a daily basis.

On Friday, the Food and Drug Administration (FDA) approved a medicine called Vyleesi that contains bremelanotide. AMAG Pharmaceuticals develops Vyleesi, which is said to be the better version of Addyi. Vyleesi is fast acting, has fewer side effects, and is not a daily dose kind of drug.

The primary goal of AMAG in developing Vyleesi is to treat women are diagnosed with Hypoactive Sexual Desire Disorder (HSDD) who are under the premenopausal stage. HSDD is a condition characterized by non-existent or low sexual desire.

Vyleesi is said to activate certain pathways in the brain to increase sexual desire in women.

The medicine has to be administered as a shot into the thigh or abdomen with an auto-injector at least an hour before sexual activity. Like Viagra, Vyleesi should not be taken more than once in any 24-hour period. Also, it should not be taken more than eight shots per month.

There is a common misconception that Vyleesi and Viagra are the same. However, experts said that Vyleesi is not a “Female Viagra.”

Vyleesi targets the brain, while Viagra targets the circulatory system so that the penile organ get enough blood for an erection.

Bremelanotide activates brain receptors, Viagra acts on the blood vessels.

“Female sexual dysfunction is more complicated in some ways than male sexual dysfunction, so it’s more difficult to treat,” said Dr. Cirino, co-director of the Menopause and Sexual Therapy Clinic.

The FDA accepted Vyleesi to treat HSDD; however, experts believe that the real cure to women with HSDD is not the single shot of this medicine.

HSDD, which is often mistaken to be a psychological disorder, is believed to affect nearly 10 percent of women of all ages. Dr. Sharon Parish, Professor of Medicine at Weill Cornell Medical College, said, “The said condition is under-recognized and clinicians don’t have a method for diagnosing or even addressing it.”

Like Addyi, Vyleesi will only increase a woman’s sexual drive, but it will not treat the underlying cause of HSDD.

In addition, experts emphasized that feeling distress is usually linked to one of the effects of HSDD. However, that alone may have several causes. There could be other factors affecting a woman’s sexual drive, such as infrequent arousal or low self-esteem.

Dr. Cirino explained, “There are so many chemical factors that influence our libido. So you can’t discount using a chemical treatment as part of the broad approach to low libido.” Vyleesi is expected to hit the market in September.