June 21 (UPI) -- The U.S. Food and Drug Administration on Friday gave its approval to Vyleesi, a drug to treat women with low sexual desire.
The FDA said Vyleesi, which is the brand name for the generic bremelanotide, can be used to treat generalized hypoactive sexual desire disorder in premenopausal women. It is not meant for low sexual desire caused by a co-existing medical or psychiatric condition, or the effects of another drug or medication.
"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," said Hylton Bone, director of the Center for Drug Evaluation and Research's Division of Bone, Reproductive and Urologic Products. "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."
Vyleesi is an injection that women must administer in the thigh or abdomen at least 45 minutes before anticipated sexual activity.
During a 24-week study, about 25 percent of patients who used Vyleesi had an increase of 1.2 or more in their sexual desire score on a range of 1.2 to 6. Seventeen percent of those who took a placebo reported an increase in sexual desire.
The most reported side effects associated with the drug were nausea, vomiting, flushing, injection site reactions and headache. The drug also causes an increase in blood pressure and is not recommended for patients with uncontrolled hypertension.
AMAG Pharmaceuticals, which manufactures the drug, welcomed the FDA's decision.
"Today's approval underscores AMAG's commitment to women's health and dedication to raising awareness and improving education about HSDD," said Julie Krop, chief medical officer at AMAG. "While HSDD is the most common female sexual dysfunction condition, it is largely under-recognized."