Should Bremelanotide Be Considered for the Treatment of Sexual Arousal and Desire Disorders in Men?
Pfaus JG, Balon R
Journal of Clinical Psychopharmacology (2026)
James Pfaus — the bench scientist whose preclinical female-rat solicitation work anchored bremelanotide's FDA approval for HSDD in premenopausal women — argues with Robert Balon in JCP that the male-population evidence has matured enough to justify clinical consideration of bremelanotide for male hypoactive sexual desire disorder, despite the drug's current female-only label.
This 2026 Journal of Clinical Psychopharmacology editorial perspective from James Pfaus (Charles University Prague and the Czech National Institute of Mental Health) and Robert Balon (Wayne State University) revisits the question of whether bremelanotide should be clinically considered for male sexual arousal and desire disorders, despite the drug's current FDA label being restricted to premenopausal women with acquired generalised hypoactive sexual desire disorder (HSDD).
The authors are an unusually well-positioned pairing for this argument: Pfaus's preclinical work on female-rat sexual-solicitation behaviour and central melanocortin-4-receptor (MC4R) modulation provided much of the mechanistic foundation for Palatin's bremelanotide development programme through the 2000s and 2010s, and Balon is one of the senior clinical-psychopharmacology authors most cited in the modern sexual-medicine literature. Their joint position carries unusual weight in a field where the female-versus-male framing of HSDD treatment has been a clinical-research bottleneck for two decades.
The editorial summarises the published evidence on bremelanotide in men, drawing on the early Palatin male-erectile-dysfunction Phase 2 work (intranasal formulation, ultimately discontinued for blood-pressure concerns), the subsequent subcutaneous-formulation male-HSDD investigation, and the broader central-melanocortin-system evidence for male sexual-function modulation. They argue that the mechanistic case (MC4R-mediated central sexual-arousal pathways are not sex-specific), the available human Phase 2-grade data (clinically interpretable effect sizes on validated male-HSDD scales), and the broader treatment-gap context (no FDA-approved pharmacotherapy for male HSDD exists) together justify clinical consideration of bremelanotide in carefully selected male patients, presumably as off-label use under specialist supervision.
The piece is explicitly an editorial perspective rather than a primary research paper or systematic review. The authors do not propose a guideline-level recommendation; they propose that the question deserves continued clinical-research investment and that the female-only label should not be read as a blanket signal that the drug does not work in men.
This is a brief editorial perspective, not a primary research paper, systematic review, or meta-analysis. The published evidence base on bremelanotide in men is substantially thinner than the female evidence base — there is no equivalent of the RECONNECT trial for male HSDD, and the historical Phase 2 male-erectile-dysfunction programme was discontinued before it produced the registration-grade data the female programme generated.
The cardiovascular safety profile of bremelanotide is the load-bearing concern that complicates the male-HSDD pitch. Transient blood-pressure elevations and the population-relevant cardiovascular-comorbidity profile of older men with sexual dysfunction together raise the bar for off-label prescribing — the female-HSDD label-population was younger, less cardiovascularly-comorbid, and pre-screened with specific contraindications that the male-HSDD population would also require.
The authors' personal histories with the drug (Pfaus's involvement in Palatin's preclinical programme; the broader sexual-medicine community's relationships with Palatin and the AMAG / Cosette successor commercial entities) are relevant context for an editorial that takes a positive view of expanding the indication. The piece reports no specific industry funding for the editorial itself, but readers should weight the authors' historical involvement.
The corpus does not have a 2025-2026 Phase 3 male-HSDD bremelanotide trial to cite — if such a trial were running and producing positive results, the editorial would presumably reference it; the absence is consistent with the broader clinical-research-funding bottleneck in male sexual medicine.
The piece is short — abstract-only extraction is the only available source for many readers, including the corpus. The full editorial likely contains more detailed evidence review and prescribing-guidance discussion that the abstract cannot capture.
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