Physical Treatments for Sexual Problems
Philipa A Brough, Margaret Denman in Introduction to Psychosexual Medicine, 2019
Flibanserin is a centrally-acting agent licenced in the United States 2 years ago for the treatment of female sexual interest/arousal disorder (FSIAD) in pre-menopausal women. More recent studies have also shown some evidence for efficacy in treating hypoactive sexual desire disorder in post-menopausal women (16). However, studies into this and other newer agents such as bremelanotide are sponsored by the pharmaceutical industry, and there has been controversy in the United States about the awarding of the US Food and Drug Administration licence.
Physiology of normal sexual function
Jacques Corcos, David Ginsberg, Gilles Karsenty in Textbook of the Neurogenic Bladder, 2015
A positive effect of bremelanotide, a nonselective agonist of MC receptors, on sexual desire in premenopausal women with sexual arousal disorder has been reported, and the clinical development of this compound is continued.107
Sexual dysfunction with major depressive disorder and antidepressant treatments: impact, assessment, and management
Published in Expert Opinion on Drug Safety, 2022
Joan Winter, Kimberly Curtis, Bo Hu, Anita H. Clayton
Bremelanotide is a melanocortin receptor agonist approved by the FDA in 2019 for the treatment of premenopausal women with generalized acquired HSDD[14]. Women treated with bremelanotide reported improvement in sexual desire, physical changes of arousal, and overall quality of sexual activities, in addition to positively impacting their perceived sexual health and relationship with sexual partners[137]. Bremelanotide is administered subcutaneously with an autoinjector at least 45 minutes prior to sexual activity, which some patients may prefer as it does not require daily dosing. Bremelanotide has shown good tolerability without risks of hypotension with concomitant oral ethanol ingestion in Phase 1 trials [138–141]. Early studies of intranasal bremelanotide demonstrated promise in the treatment of erectile dysfunction, thus there may also be benefit in its use for treatment of sexual dysfunction in men[142]. There are not yet studies assessing the role of bremelanotide in TESD or concomitant administration with antidepressants.
Evaluation of safety for flibanserin
Published in Expert Opinion on Drug Safety, 2020
Anita H Clayton, Louise Brown, Noel N Kim
As a multifunctional serotonin agonist and antagonist, flibanserin is a first-in-class non-hormonal therapy for the treatment of HSDD. Another recently approved medication for treating premenopausal women with HSDD is bremelanotide, a melanocortin receptor agonist that is administered by subcutaneous injection at least 45 minutes before anticipated sexual activity [51]. The most common AEs (placebo-corrected) associated with bremelanotide therapy were nausea (38.7%), flushing (20%), headache (9.4%), injection site reactions (4.8%), and vomiting (4.6%). In bremelanotide-treated patients experiencing nausea, 13% required anti-emetic therapy and 8% discontinued from the trial. Focal hyperpigmentation (face, gingiva and breasts) was reported in 1% of patients in phase 3 placebo-controlled trials. Transient increases in blood pressure and reductions in heart rate also occurred after administration but usually resolved within 12 hours. Bremelanotide is not recommended for patients at high risk for cardiovascular disease and is contraindicated in patients with uncontrolled hypertension or known cardiovascular disease.
Re-Analyzing Phase III Bremelanotide Trials for “Hypoactive Sexual Desire Disorder” in Women
Published in The Journal of Sex Research, 2021
The present analysis is limited in several ways. First, only two Phase III trials of bremelanotide were analyzed. Perhaps additional trials of bremelanotide would yield differing results. There is at least one other placebo-controlled trial of bremelanotide from an earlier phase in its development (Clayton et al., 2016). However, as a) FDA considers phase III trials to be “pivotal” in determining whether to approve a drug, b) usable data from the FDA NDA from the phase III (but not earlier phase) trials are available, and c) the phase II trial included women with DSM-IV diagnoses of female sexual arousal disorder, whereas Kingsberg et al. (2019) excluded participants with any female sexual dysfunction other than HSDD, only the two phase III trials were included in the current re-analysis. Nonetheless, the Phase II trial is briefly described for the sake of completeness (Clayton et al., 2016). The study used three different dosages, with one group receiving the 1.75 mg dose later used in the Phase III trials. Seven protocol-specified outcomes were listed in the study’s clinicaltrials.gov entry (Palatin Technologies, 2014), three of which were not reported in the Clayton et al. (2016) article. A subset of outcomes were reported among participants with either an exclusive or primary HSDD diagnosis. Briefly, for the 1.75 mg dose, Clayton et al. found statistically significant efficacy for bremelanotide on three of five reported outcomes among patients with either an exclusive or primary HSDD diagnosis.
Related Knowledge Centers
- Female Sexual Arousal Disorder
- Hypoactive Sexual Desire Disorder
- Peptide
- Thigh
- Abdomen
- Menopause
- Subcutaneous Administration
- Agonist
- Melanocortin Receptor
- First-In-Class Medication