Bremelanotide for Hypoactive Sexual Desire Disorder

Bremelanotide for Hypoactive Sexual Desire Disorder

• female sexual dysfunction comprises a group of sexual disorders related to desire, arousal, and interest, as well as orgasm
• hypoactive sexual desire disorder
  • is defined as the persistent or recurrent deficiency or absence of sexual fantasies or thoughts and desire for -or receptivity to -sexual activity, is the most prevalent female sexual dysfunction associated with personal distress and is not explained by another mental disorder, medical condition, or medications (1)
  • may be caused by an imbalance in the excitatory and inhibitory neural pathways in the prefrontal cortex and limbic system implicated in human sexual response, leading to increased inhibition, decreased excitation, and diminished responsiveness to sexual cues
    • melanocortins have been associated with excitatory pathways and linked to appetitive sexual behaviors
  • according to a U.S.-based survey study, hypoactive sexual desire disorder occurs in 8.9% of women aged 18-44 years, 12.3% of women aged 45-64 years, and 7.4% of women aged 65 years or older (1)

Bremelanotide is a novel cyclic heptapeptide analog of the endogenous neuropeptide alpha-melanocyte-stimulating hormone with high affinity for the melanocortin-4 receptor

• two identical phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trials (RECONNECT) evaluated the safety and efficacy of bremelanotide 1.75 mg administered subcutaneously as needed in premenopausal women with hypoactive sexual desire disorder
• studies demonstrated that bremelanotide significantly improved sexual desire and related distress in premenopausal women with hypoactive sexual desire disorder (2)
  • safety profile was favorable
  • most treatment-emergent adverse events were related to tolerability and the majority were mild or moderate in intensity

Reference:

• Simon JA, Kingsberg SA, Portman D, et al. Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder. Obstet Gynecol. 2019;134(5):909-917. doi:10.1097/AOG.0000000000003514
• Kingsberg SA, Clayton AH, Portman D, et al. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstet Gynecol. 2019;134(5):899-908. doi:10.1097/AOG.0000000000003500