FDA Approves New Treatment for Hypoactive Sexual Desire Disorder in Women

The United States Food and Drug Administration (FDA) approved bremelanotide (Vyleesi) on June 21, 2019 to treat hypoactive sexual desire disorder (HSDD) in premenopausal women (those who have not undergone menopause).

"There are women who have reduced sexual desire for a known reason, causing significant distress, who could benefit from safe and effective pharmacological treatment. Today's approval provides women with another treatment option for this condition," says Dr. Hylton V. Joffe, Director of the Division of Bone, Reproductive and Urologic Products at the FDA Center for Drug Evaluation and Research.

What Is Hypoactive Sexual Desire Disorder (HSDD) in Women?

Hypoactive sexual desire disorder (HSDD) in women is characterized by low sexual desire that causes marked distress or interpersonal difficulty, is not accompanied by a medical or psychiatric condition, and is not due to relationship problems or the effects of a medication.

Acquired hypoactive sexual desire disorder develops in a patient who has not previously had problems with sexual desire. Generalized hypoactive sexual desire disorder refers to the disorder occurring regardless of the type of sexual activity, situation or partner.

How Does Bremelanotide Work?

Vyleesi activates melanocortin receptors, but the mechanism by which it increases sexual desire and related distress is not fully understood.

Patients inject Vyleesi under the skin of the abdomen or thigh at least 45 minutes before anticipated sexual activity, and can determine the best timing based on how long they benefit and how they experience side effects such as nausea. Patients should not use more than one dose within 24 hours or more than eight doses per month. Patients should discontinue treatment after eight weeks if they report no improvement in sexual desire and related distress.

Studies Leading to FDA Approval

The effectiveness and safety of Vyleesi were studied in 1247 premenopausal women with acquired hypoactive sexual desire disorder in 24-week, randomized, double-blind, placebo -controlled trials. Most patients used Vyleesi two or three times a month (no more than once a week). In these studies, approximately 25% of patients treated with Vyleesi had an increase of 1.2 or more in sexual desire scores (on a scale of 1.2 to 6.0, with higher scores indicating greater sexual desire). In addition, approximately 35% of patients treated with Vyleesi had a decrease of one or more in distress scores. However, Vyleesi does not improve sexual performance.

Side Effects

The most common side effects of Vyleesi are nausea and vomiting, flushing, injection site reactions and headache. In clinical trials, approximately 40% of patients experienced nausea, most often with the first Vyleesi injection, and 13% needed medication to treat nausea. Approximately 1% of patients treated with Vyleesi in clinical trials reported darkening of the skin and areas of the skin, including the face and breasts; in approximately half of these patients, this did not go away after treatment was stopped. Patients with darker skin were more likely to develop this side effect.

In clinical trials, Vyleesi increased blood pressure after administration, which generally resolved within 12 hours. Because of this effect, Vyleesi should not be used in patients with uncontrolled high blood pressure or known cardiovascular disease. Vyleesi is also not recommended for patients at high risk of cardiovascular disease .

When naltrexone is taken orally, Vyleesi can significantly reduce blood levels of naltrexone. Patients taking an oral medication containing naltrexone to treat alcohol or opioid dependence should not use Vyleesi, because it may lead to naltrexone treatment failure.

In 2012, the FDA identified female sexual dysfunction as one of 20 disease areas warranting high priority and focused attention. The FDA held a two-day meeting in October 2014 to improve its understanding of female sexual dysfunction. During the first day, the FDA sought patients' direct perspectives on their conditions and their effects on daily life. In 2016, the FDA published draft guidance to help companies developing drugs to treat these conditions, titled "Low Sexual Interest, Desire and/or Arousal in Women: Developing Drugs for Treatment." The FDA remains committed to working with companies to develop safe and effective treatments for female sexual dysfunction.