(020) Real-World Use of Bremelanotide in One Sexual Medicine Clinic Treating Women with Hypoactive Sexual Desire Disorder

Abstract

Abstract Introduction Hypoactive sexual desire disorder (HSDD) is the most common sexual dysfunction in women, afflicting approximately 10%. The melanocortin 4 receptor agonist bremelanotide is FDA approved as the only on-demand treatment for premenopausal women with generalized, acquired HSDD. A recent randomized, double-blind, placebo-controlled, crossover study using functional MRI showed that this medication acts on relevant dopamine brain centers to reduce self-consciousness, increase self-imagery, and sensitize women with HSDD to erotic stimuli. Since its availability in late 2019, providers in our facility have been prescribing bremelanotide to women who have been diagnosed with HSDD after having undergone a biopsychosocial evaluation. Objective Data from phase 2 and 3 bremelanotide clinical trials in women with HSDD do not necessarily translate into real-world experience from patients at a sexual medicine facility. The goal of this research was to gain, for the first time, a better understanding of use of bremelanotide by analyzing our clinic prescribing patterns and refill rates over the last 3 years of our female patients with HSDD. Methods Bremelanotide prescription dispensing data specific to one sexual medicine facility during the period of late 2019 (inception) through November 2022 was compiled. The analysis included the breakdown of prescription dispenses on label to premenopausal (categorized by age 18-50) and off label to postmenopausal (categorized by age ≥51) women, with further analysis and breakdown regarding refills and refill rates. Results Prescriptions generated at our facility over the last 3 years have resulted in bremelanotide being dispensed 64 times to premenopausal women and 97 times to postmenopausal women diagnosed with HSDD. For premenopausal women, 25% of these dispenses were refills and for postmenopausal women, 54% were refills. Calculating prescription dispense refill rates cumulatively each year reflected premenopausal refill rates of 10% for 2019-2020, 17% for 2019-2021 and 25% for 2019-2022. Postmenopausal refill rates were 43% for 2019-2020, 52% for 2019-2021 and 54% for 2019-2022. Notably, for 2021-2022, refill rates were 37% for premenopausal women and 65% for postmenopausal women. Conclusions The refill rate of any medication reflects, in part, the safety and efficacy of the treatment in a real-world setting. We observed an increasing and high refill rate of bremelanotide in both premenopausal and postmenopausal women, that likely reflects the successful management of HSDD with this on demand treatment in both populations. As more women are becoming aware of the diagnosis and available treatments for HSDD, there is a need for more providers to become familiar with the disease state and the treatment options including sex therapy and medications. It is anticipated that over time, treatments will be provided more commonly to women with HSDD by the medical community and expected more often by women in the general population, similar to what occurred after the development and FDA approval of sildenafil, an on-demand medication for men with erectile dysfunction. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Palatin Technologies, Inc.