Bremelanotide (Vyleesi™): a new treatment for hypoactive sexual desire disorder in premenopausal women

Bremelanotide (Vyleesi™): a new treatment for hypoactive sexual desire disorder in premenopausal women

Jamie Erickson, PharmD, Cashwise Clinic Pharmacy/Carris Health

In June 2019, the FDA approved bremelanotide (Vyleesi™), a subcutaneous autoinjector for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. Generalized HSDD is characterized by a low sexual desire that is present regardless of one’s sexual activity, situation, or partner and causes marked distress or interpersonal difficulty. This treatment should not be used for HSDD caused by a co-existing medical or psychiatric condition, relationship complications, or as a result of medication or other drug substance. Bremelanotide is not indicated for the treatment of HSDD in postmenopausal women, men, or to enhance sexual performance. 

The mechanism by which bremelanotide improves HSDD in women is unknown; however, it is a nonselective melanocortin receptor (MCR) agonist. Bremelanotide is administered as a 1.75 mg subcutaneous injection in the abdomen or thigh at least 45 minutes prior to anticipated sexual activity. It should not be used more than once in 24 hours or more than eight doses per month. The efficacy of bremelanotide was studied in two identical, Phase 3, 24-week, randomized, double-blind, placebo-controlled trials. Approximately 25% of patients treated with bremelanotide and 17% of patients treated with placebo had an improvement in sexual desire score of 1.2 or moreusing the Female Sexual Function Index (FSFI). In addition, approximately 35% of patients treated with bremelanotide and 31% of patients treated with placebo had an improvement in the level of distress associated with low sexual desire score of 1 or more using the Female Sexual Distress Scale – Desire/Arousal/Orgasm Question 13 (FSDS-DAO Q13). 

The most notable adverse effects seen with bremelanotide treatment are nausea (most commonly with first injection), flushing, injection site reactions, headache, and transient increases in blood pressure and reductions in heart rate. Bremelanotide is contraindicated for use in patients with cardiovascular disease or uncontrolled hypertension and it is not recommended for use in patients at high risk for cardiovascular disease. Potentially irreversible focal hyperpigmentation of the face, gingiva, and breasts is a rare side effect that is more common in patients with dark skin. Bremelanotide can be used as needed, which may be an advantage over flibanserin (Addyi®), which is a daily oral treatment for HSDD in premenopausal women. Bremelanotide is not yet available in pharmacies but the average wholesale price is $1078.80 per box containing four single-dose autoinjectors. 

References: 

  1. Vyleesi™ (bremelanotide) [package insert]. Waltham, MA: AMAG Pharmaceuticals, Inc.; 2019.
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210557s000lbl.pdf. Accessed August 12, 2019.

  1. U.S. Food & Drug Administration. FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-hypoactive-sexual-desire-disorder-premenopausal-women. Published June 21, 2019. Accessed August 12, 2019. 

  2. Shifren, JL. Overview of sexual dysfunction in women: Management. In: Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc; 2019. https://www.uptodate.com/contents/overview-of-sexual-dysfunction-in-women-management?search=hsdd&source=search_result&selectedTitle=1~20&usage_type=default&display_rank=1. Accessed August 12, 2019. 

  3. Active Ingredient: Bremelanotide. RED BOOK Online. Micromedex Healthcare Series [database online]. Greenwood Village, CO: Truven Health Analytics; 2019. https://www-micromedexsolutions-com.ezp3.lib.umn.edu/micromedex2/librarian/CS/231945/ND_PR/evidencexpert/ND_P/evidencexpert/DUPLICATIONSHIELDSYNC/80D546/ND_PG/evidencexpert/ND_B/evidencexpert/ND_AppProduct/evidencexpert/ND_T/evidencexpert/PFActionId/redbook.ShowProductSearchResults?SearchTerm=VYLEESI&searchType=redbookProductName&searchTermId=49422&searchContent=REDBOOK&searchFilterAD=filterADActive&searchFilterRepackager=filterExcludeRepackager&searchPattern=%5Evyleesi Accessed August 12, 2019.