U.S. FDA approves Vyleesi (Bremelanotide) for use in hyposexuality in premenopausal women
HSDD is one of the most common sexual dysfunctions in women and affects approximately 6 million premenopausal women in the United States. The main manifestation of HSDD is decreased sexual desire and mental stress, which often affects women's emotional health, intimacy and overall quality of life.
Recently, the US FDA announced that it has approved the listing of Vyleesi (Bremelanotide) jointly developed by AMAG Pharmaceuticals and Palatin Technologies for the treatment of hyposexuality (HSDD) in premenopausal women.
About Vyleesi (Bremelanotide)
Vyleesi is a "first-in-class" innovative agonist of melanocortin 4 receptor (MC4R). The new drug can be used through an automatic disposable syringe before an anticipated sexual activity, and HSDD patients do not need to use this therapy daily.
FDA approval is based on Vyleesi's performance in a Phase 3 clinical research project called RECONNECT. The study included two randomized, double-blind, placebo-controlled, phase 3 clinical trials involving a total of 1,247 premenopausal patients.
The trial results showed that both trials reached the trial's common primary endpoint, with a significant improvement in the sexual desire index score of 25% of women receiving treatment, which was significantly better than the placebo group (17%). At the same time, Bremelanotide reduces the anxiety caused by HSDD.