*Content reviewed by HotPause Health Medical Advisor & Doctor of Pharmacy Audrey Hou, PharmD, CMPP

The U.S. Food and Drug Administration (FDA) has approved Vyleesi (bremelanotide) for the treatment of acquired, generalized Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women. This approval offers new hope for women experiencing low sexual desire that leads to marked distress, and who are seeking an effective pharmacological option.

How Vyleesi Works

Vyleesi acts on melanocortin receptors, although the exact mechanism by which it enhances sexual desire and alleviates distress is still under investigation. Unlike daily treatments, Vyleesi is used as needed by administering an injection under the skin of the abdomen or thigh at least 45 minutes before anticipated sexual activity. This allows users to manage the timing based on their experiences of the benefits and any side effects, such as nausea.

Who Should Consider Vyleesi

Vyleesi is specifically designed for premenopausal women with acquired, generalized HSDD. This condition is characterized by a significant decrease in sexual desire that is not attributed to medical or psychiatric conditions, relationship issues, or the use of other medications or substances. It affects women who previously had no problems with sexual desire and occurs regardless of the type of sexual activity, the situation, or the partner. Common symptoms associated with HSDD are an absence of sexual fantasies, thoughts, and/or desire for or receptivity to sexual activity.

Potential Benefits of Vyleesi for Menopause

• Vyleesi offers several benefits for premenopausal women struggling with HSDD:
  • Improvement in Sexual Desire: Many women report an increase in sexual desire, helping to alleviate the distress associated with HSDD.
  • Flexibility in Use: As an on-demand treatment, Vyleesi provides flexibility, allowing women to use it only when needed and plan around their sexual activity.
  • Improvement in Psychological Well-being: The reduction in distress about sexual desire can contribute to overall improvements in mood and quality of life.

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Usage and Considerations

• Administration: Patients inject Vyleesi under the skin at least 45 minutes ahead of sexual activity.
• Frequency: No more than one dose should be used within 24 hours, and no more than eight doses should be used per month.
• Evaluation Period: If there is no noticeable improvement in sexual desire and associated distress after eight weeks of treatment, discontinuation of the medication is recommended.

Side Effects and Considerations

• Common Side Effects: The most frequent side effects include nausea, vomiting, flushing, injection site reactions, and headache.
• Potential Skin Changes: About 1% of patients may experience darkening of the gums and skin on certain parts of the body, including the face and breast, which may be irreversible in some cases.
• Cardiovascular Concerns: Vyleesi can cause a temporary increase in blood pressure and decrease in heart rate, making it unsuitable for women with uncontrolled high blood pressure or known cardiovascular disease.
• Interaction with Naltrexone: Vyleesi can reduce the effectiveness of oral naltrexone used to treat alcohol or opioid dependence.

Conclusion

Vyleesi represents a significant advancement in the treatment options available for premenopausal women suffering from HSDD. It provides a needed alternative for those who can benefit from pharmacologic treatment to manage this challenging condition effectively. As with any medication, women interested in Vyleesi should discuss it with their healthcare provider to ensure it is the appropriate treatment based on their health status and medical history.