FDA Approval: Everything You Need To Know About The Viagra Drug For Women

The U.S. Food and Drug Administration (FDA) has approved a Viagra-like drug for women called Vyleesi. The drug is designed to treat generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

Women with HSDD have a low sexual desire that is often characterized by distress or interpersonal difficulty that previously had no issues with sexual desire, the FDA said. The drug is manufactured by AMAG Pharmaceuticals (AMAG), which received approval from the FDA after the agency identified HSDD as one of the 20 disease areas of high priority.

“There are women who, for no known reason, have reduced sexual desire that causes marked distress, and who can benefit from safe and effective pharmacologic treatment,” 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, said.

“Today’s approval provides women with another treatment option for this condition. As part of the FDA’s commitment to protect and advance the health of women, we’ll continue to support the development of safe and effective treatments for female sexual dysfunction.”

To create a Viagra like effect in women, Vyleesi activates melanocortin receptors in the brain, which helps to increase sexual desire and distress. The drug is injected under the skin at the abdomen or thigh at least 45 minutes before sexual activity is projected to occur. Only one dose is recommended every 24 hours, and no more than eight does are recommended a month.

Side effects of Vyleesi include nausea and vomiting as well as flushing, injection site reactions, and headaches. Skin discoloration can also occur in some women. The drug also should not be used with women that have high blood pressure as it can increase blood pressure in the first 12 hours of dosage. It is also not recommended for women with cardiovascular disease.

Shares of AMAG Pharmaceuticals stock were up 3.04 percent as of 3:30 p.m. ET on Tuesday.