works on melanocortin receptors on cells, the FDA said.
The drug is injected under the skin of the abdomen or thigh at least 45 minutes prior to a sexual encounter, although the best timeframe for dosing could vary from user to user.
Side effects can occur, the FDA added, and include nausea and vomiting, flushing, injection site reactions and headache. Nausea was especially common, affecting 40% of users in the clinical study that led to approval.
That study involved 1,247 premenopausal women with HSDD who received Vyleesi or a placebo in one of two 24-week trials.
“In these trials, about 25% of patients treated with Vyleesi had an increase of 1.2 or more in their sexual desire score (scored on a range of 1.2 to 6.0, with
