The U.S, Food and Drug Administration just approved a new treatment for general hypoactive sexual desire disorder (HSDD) in premenopausal women.
What is HSDD?
Vyleesi FDA Approval
On June 21, the U.S. FDA announced the approval of AMAG Pharmaceuticals’ autoinjector treatment for HSDD, Vyleesi. According to the director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products, Hylton V. Joffe, M.D., M.M.Sc., the approval is a part of the FDA’s commitment to support the development of effective and safe treatments for sexual dysfunctions in women.
The product is injected in the thigh or abdomen about 45 minutes before the possible sexual activity, but may only be used once in 24 hours. Anyone who does not experience an improvement in sexual desire in eight weeks must discontinue the use of the product
“Today’s approval underscores AMAG’s commitment to women’s health and dedication to raising awareness and improving education about HSDD. While HSDD is the most common female sexual dysfunction condition, it is largely under-recognized,” said the chief medical officer of AMAG, Julie Krop, M.D., also thanking the thousands of women who participated in the clinical trials.
According to the FDA, Vyleesi works by activating melanocortin receptors, but the actual mechanisms behind how it affects sexual drive are unknown.
Hypoactive Sexual Drive Disorder
HSDD is a condition that is characterized by low sexual desire in that causes distress or interpersonal difficulties, and is not a result of other factors such as drug substance, medication, or medical or psychiatric conditions.
The condition is believed to have a neurobiologic basis, and those who have it may avoid situations that lead to intimacy, and may result in anxiety, relationship issues, and self-esteem issues. Unfortunately, while it has been recognized as a medical condition since the 1970s, it has remained undertreated and underdiagnosed.
That said, in 2012, the FDA deemed female sexual dysfunctions as one of the top 20 diseases of high priority and focused attention, and in October of 2014 held a two-day meeting to help increase the agency’s knowledge on the matter.