Unmet needs in the treatment of erectile dysfunction and a place for topical treatments in the therapeutic landscape.

BACKGROUND: Systemic therapy with phosphodiesterase type 5 inhibitors (PDE5is) is the standard of care for erectile dysfunction (ED), but these treatments are not effective in all men, and others may prefer non-systemic treatment options. AIM: The goal of this Delphi consensus initiative was to address unmet needs in the treatment of men with ED and the best use of a US Food and Drug Administration (FDA) cleared topical therapy, MED3000 (Eroxon®), that is available without a prescription. METHODS: The iterative Delphi process involved the creation of an initial slate of 38 statements and brief summaries of related evidence (if available), followed by the review from 2 co-chairs and 3 rounds of consensus development by an independent panel. OUTCOMES: The Delphi process reduced the initial set of 38 statements to 31 for which there was ≥80% support (in some cases after revision of the initial statement and revoting) from the panel in the final round of voting. RESULTS: Statements for which consensus was achieved were consistent with current guidelines in recognizing the need for topical ED therapy. They also provided practical expert advice on the best use of this topical therapy. Statements regarding MED3000 (Eroxon®) for which consensus was not achieved identified important clinical considerations that would benefit from further analysis of existing clinical trial results for MED3000 and collection of new real-world data. CLINICAL IMPLICATIONS: This initiative identified multiple unmet needs that may be addressed by a well-tolerated and efficacious topical treatment. It also provided a critical assessment from experienced healthcare professionals of the evidence supporting the use of an over-the-counter topical therapy for ED. STRENGTHS AND LIMITATIONS: The main strength of this Delphi initiative was an expert assessment of unmet needs in ED and the place in therapy for topical medications. The main limitation was that available data for topical treatment leaves some questions unanswered, most notably efficacy in different subpopulations of men with ED. CONCLUSIONS: Overall, the statements supported in this Delphi initiative may provide a framework for more detailed recommendations that could be incorporated into treatment guidelines. In addition, the statements for which unanimous support could not be achieved help to identify evidence gaps that are targets for future research.