July 3, 2019
The drug is injectable, and the manufacturer—Waltham, Massachusetts-based AMAG Pharmaceuticals—says it should be self-administered by placing the needle under the skin of the adbdomen or thigh and pushing the plunger, at least 45 minutes before sexual activity.
But, the pharmaceutical company also advises that patients, themselves, should decide on the “optimal time” ahead of intercourse for the injection because the drug has side effects that can ruin the mood—among them, nausea and vomiting, flushing, injection site reactions, and headaches.
About 40% of patients in the clinical trials experienced nausea, most commonly with the first Vyleesi injection; and 13% needed medications for the treatment of nausea. About 1% of patients treated with Vyleesi in the clinical trials reported darkening of the gums and parts of the skin, including the face and breasts—which did not go away in about half the patients after stopping treatment. Patients with dark skin were more likely to develop this side effect.
How does it work? Vyleesi activates melanocortin receptors, but the mechanism by which it improves sexual desire and related distress is unknown.
Still, the FDA says that this drug represents an advance in treating low sexual desire, for women and their partners affected by this problem.
“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. Today’s approval provides women with another treatment option for this condition,” said 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.
The approval of Vyleesi by the FDA follows the agency’s 2015 approval of Addyi, which also was designed to boost libido, but which no one really wanted. (Its sales are currently “tepid,” according to a recent report by The New York Times. Addyi also caused fainting when combined with alcohol.)
Research contact: @US_FDA