(035) USE OF BREMELANOTIDE IN MEN WITH SEXUAL DYSFUNCTION AT A SEXUAL MEDICINE CLINIC
Authors: Goldstein SW , Goldstein I 
Published: December 2024

Abstract

Introduction
Bremelanotide (Vyleesi), a non-hormonally based CNS medication, was FDA approved for premenopausal women with generalized, acquired hypoactive sexual desire disorder (HSDD) in 2019. It modulates central dopaminergic pathways involved in sexual desire, arousal and orgasm and is reported to increase genital blood flow in women and men within hours of subcutaneous administration. Our clinic has been prescribing bremelanotide off-label to men with sexual dysfunctions (SD) since its approval.

Objective
To better understand the use of bremelanotide prescribed to men who underwent a biopsychosocial evaluation in our clinic, we evaluated prescribing patterns, improvements in sexual function, overall satisfaction, and side effects.

Methods
Bremelanotide prescription dispensing data from our facility was compiled September 2019 through June 2023 and analyzed for prescribing patterns and refill rates for all patients. A one-group study design interview trial of men with SD prescribed bremelanotide was performed. After signing consent, participants answered the Quality of Life Dimension of Sexual Quality of Life Questionnaire, Patient Global Impression of Improvement (PGI-I) and General Assessment Questions. After answering questionnaires online, participants completed a structured interview on the telephone with a single interviewer. Descriptive statistics characterized the study cohort. Adverse events were collected.

Results
Over the 46-month period, bremelanotide has been dispensed to men for SD 444 times; 65% of dispenses were refills. In comparison, during that same time period, the medication was prescribed 76 times to premenopausal women with 29% refills, and 104 times to postmenopausal women with 52% being refills. Over a recent 18 period, refill rates have been 73% (n = 219) for men, in contrast to 47% for premenopausal women (n = 30), 52% for postmenopausal women (n = 29). These data resulted in an interest in learning more about the experiences of the men using bremelanotide for HSDD and other SD. At the time of this interim analysis, 23 men signed consent and 22 completed online questionnaires. 76% of these men were more satisfied with their lovemaking and duration of lovemaking; 83% reported vaginal insertion was easier and 65% said it was easier to orgasm. Concerning feelings about initiating lovemaking, 76% were more at ease and 75% anticipated it would be more pleasurable and 71% more carefree. 56% believed orgasm was more pleasurable and 65% said that lovemaking was more pleasurable while 71% reported that the partner’s overall experience was more pleasurable. Using the PGI-I, 70% of participants felt that sexual function after using bremelanotide was a little better, much better, or very much better. The interview revealed that in men for whom bremelanotide worked, they had improvement in HSDD (39%), erectile dysfunction (52%), orgasm (17%), and anxiety about sexual performance (39%). Side effects included nausea (30%), flushing (22%), headache (13%), bothersome spontaneous erections without sexual stimulation for about 24 hours after injection (13%), and incontinence, cramping and abdominal burning (4% each). All adverse events were transient.

Conclusions
In our clinic, men prescribed centrally-acting bremelanotide off-label for SD filled and refilled their prescriptions more often than women. Our study showed that bremelanotide safely and effectively improved multiple SDs for some men.

Disclosure
Yes, this is sponsored by industry/sponsor: Palatin.
Clarification: Industry funding only - investigator initiated and executed study.
Any of the authors act as a consultant, employee or shareholder of an industry for: TRT, MTS.