WHAT’S BEING CLAIMED:
- The Food and Drug Administration has announced a newly approved drug that will address the condition called hypoactive sexual desire disorder (HSDD) in premenopausal women.
- Marketed as Vyleesi and to be sold by AMAG Pharmaceuticals, the new injectable drug is confirmed by the FDA as a safe and effective option for women who experience lowered libidos.
- About 10 percent of adult women suffer from HSSD, a condition that often leads to distress.
Soon to hit the market is a newly approved drug aimed to increase women’s libidos, according to announcements from the Food and Drug Administration.
Bremelanotide has been validated by the agency to treat hypoactive sexual desire disorder (HSDD) in premenopausal women. Marketed as Vyleesi, the injectable drug will be sold by AMAG Pharmaceuticals.
According to an article published in January 2017 in the Mayo Clinic Proceedings medical journal, an estimated 10 percent of adult women suffer from HSSD. Characterized by a low sexual desire, the condition often leads to distress or interpersonal difficulty.
In a statement from Hylton V. Joffe, M.D., M.M.Sc., director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products, he said that women who, for unknown reasons, experience reduced sexual desire can benefit from “safe and effective pharmacologic treatment.”
Vyleesi, unlike the once-daily pill Addyi that was introduced in 2015 to treat HSDD, stimulates melanocortin receptors. The drug is injected into the abdomen or thigh 45 minutes before patients are about to engage in sexual activity. It is also advised that patients should not use it for more than once every 24 hours, or over eight times a month.
In two, 24- week trials, where over 1,200 women were tested, the FDA revealed that sexual desire for 25 percent of patients who used Vyleesi had been boosted.
Nausea is reportedly the most common side effect as well as vomiting, flushing, injection site reactions and headaches which were experienced by 40 percent of the women.
Vyleesi is not recommended for women suffering from hypertension or heart diseases because the drug increases blood pressure temporarily.
While the cost has not yet been released, AMAG officials told the New York Times that that Vyleesi is expected to be covered under insurance just like Addyi and male erectile dysfunction drugs.
“We’re obviously thrilled about being able to bring another option to these women who have suffered significantly, pretty much in silence, for a stigmatized condition, many of whom have not known that it’s a treatable medical condition,” AMAG’s chief medical officer Dr. Julie Krop told the Times.