Can postmenopausal women use Vyleesi (bremelanotide)?

Bremelanotide (Vyleesi) Use in Postmenopausal Women

Bremelanotide (Vyleesi) is not recommended for use in postmenopausal women as it is only FDA-approved for premenopausal women with hypoactive sexual desire disorder (HSDD).

Approved Indications and Evidence

Bremelanotide is specifically approved for the treatment of acquired, generalized HSDD in premenopausal women only. The safety and efficacy of this medication were established through two phase III randomized clinical trials (RECONNECT) that exclusively enrolled premenopausal women 1. These studies demonstrated that bremelanotide significantly improved sexual desire and reduced distress related to low sexual desire compared to placebo in premenopausal women.

Treatment Options for Postmenopausal Women with Sexual Dysfunction

For postmenopausal women experiencing sexual dysfunction, the following evidence-based options are recommended instead:

Non-Pharmacological Options (First-Line)

• Hormone-free lubricants and moisturizers (water-based gel, hyaluronic acid gel) 2
• Vaginal dilators for pain during sexual activity 3
• Pelvic floor physical therapy 3
• Cognitive behavioral therapy (CBT) 3, 2
• Lifestyle modifications (weight management, smoking cessation, limiting alcohol) 2

Pharmacological Options for Postmenopausal Women

1. For vaginal dryness/dyspareunia:

   • Topical vaginal therapies (OTC or prescription) 3
   • Vaginal DHEA (prasterone) - shown to improve sexual desire, arousal, pain, and overall sexual function 3
   • Ospemifene - for moderate-to-severe dyspareunia in women without history of estrogen-dependent cancers 3, 2

2. For low sexual desire:

   • Transdermal testosterone - effective for HSDD in postmenopausal women 4
   • Off-label options that may be considered include bupropion and buspirone 3

Special Considerations for Breast Cancer Survivors

For postmenopausal women with a history of hormone-dependent cancers (particularly breast cancer):

• Systemic hormone therapy is generally contraindicated 2
• DHEA should be used with caution in survivors receiving aromatase inhibitor therapy 3
• Non-hormonal pharmacotherapy options for hot flashes include venlafaxine, gabapentin, or clonidine 2

Clinical Decision Algorithm

1. Assess the type and severity of sexual dysfunction symptoms
2. Start with non-pharmacological approaches (lubricants, moisturizers, CBT, lifestyle modifications)
3. If symptoms persist:
   • For vaginal dryness/pain: Consider topical therapies, vaginal DHEA (if no contraindications)
   • For low desire: Consider transdermal testosterone (if no contraindications)
   • For women with history of hormone-dependent cancers: Prioritize non-hormonal options

Important Caveats

• Bremelanotide has not been studied in cancer survivors or postmenopausal women 3
• The most common adverse reaction to bremelanotide is nausea (40%) 5
• The clinical benefit of bremelanotide appears to be modest, with patients experiencing approximately one additional satisfying sexual event every 2 months 3
• Safety data for androgen-based therapy in survivors of hormonally mediated cancers are limited 3

In conclusion, while bremelanotide represents an advancement in treating HSDD, its use should be restricted to the premenopausal population for which it was studied and approved. Postmenopausal women should be directed to treatments with established safety and efficacy for their age group and medical history.