The Food and Drug Administration has approved bremelanotide (Vyleesi), a melanocortin receptor agonist, for the treatment of generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. HSDD is characterized by sexual desire that is so low as to be personally distressing and interfere with a woman's personal relationships. The woman may experience an absence of sexual fantasies or thoughts, a lack of desire for sexual activity, or a lack of receptivity to sexual activity. To receive bremelanotide for HSDD, the disorder must not be secondary to a coexisting medical or psychiatric condition, result from a specific problem in a relationship, or be an adverse effect of a medication or nonprescribed drug. Bremelanotide is not for use in men or postmenopausal women or to enhance sexual performance.

Bremelanotide was studied in two randomized, double-blind, placebo-controlled trials that compared the 1.75-mg dose with placebo in 1,247 premenopausal women with HSDD. The drug was found to produce modest, but statistically significant, changes in the subjects' self-reporting on scales measuring desire and sexual distress. More women receiving the drug, compared with those who received placebo, dropped out of the study because of nausea. This complicated interpretation of the data.

Bremelanotide carries a warning that it can temporarily increase blood pressure and decrease heart rate. In clinical trials, changes in blood pressure (up to 6 mmHg in systolic blood pressure and 3 mmHg in diastolic blood pressure) and heart rate (up to 5 beats per minute) peaked between two to four hours postdose and usually resolved within 12 hours of taking the drug. Bremelanotide, therefore, is contraindicated in patients with uncontrolled hypertension or known cardiovascular disease. In clinical trials, focal hyperpigmen-tation was reported in 1% of patients receiving bremelanotide. Skin color changes were noted in the face, gingiva, and breasts and in some cases were permanent. Patients with darker skin and those using the drug daily were at greater risk for this adverse effect. Forty percent of patients who received up to eight monthly doses of bremelanotide experienced nausea, and for some the nausea was severe enough to require antiemetics or discontinuation of the drug. Most patients experience less nausea by the second dose. The other most common adverse effects (seen in at least 2% of patients) are flushing, injection site reactions, headache, and vomiting.

Bremelanotide is administered subcutaneously at least 45 minutes before anticipated sexual activity. To minimize the risk of cardiovascular complications, patients should take no more than one dose in 24 hours. Using bremelanotide more than eight times a month is not recommended, as this increases the risk of hyperpigmentation.

Bremelanotide is not recommended during pregnancy, as it has not been studied in pregnant women. Women of childbearing age should use appropriate contraception while taking bremelanotide. If pregnancy occurs, the drug should be discontinued.

Because bremelanotide slows gastric emptying, it can impair the absorption of concurrently administered oral drugs. In the case of oral naltrexone (used to treat addiction) its circulating levels may be sufficiently lowered to decrease its effectiveness.

NPs should assess the patient's blood pressure and ensure that hypertension is controlled prior to starting bremelanotide. Patients should be encouraged to not take the drug more frequently than recommended to avoid elevations in blood pressure and hyperpigmen-tation.

For complete prescribing information for bremelanotide, go to http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210557s000lbl.pdf.