PD52-07 EFFICACY AND SAFETY OF MED3000, A NOVEL TOPICAL THERAPY FOR THE TREATMENT OF ERECTILE DYSFUNCTION

You have accessJournal of UrologySexual Function/Dysfunction: Medical, Hormonal & Non-surgical Therapy II (PD52)1 May 2024PD52-07 EFFICACY AND SAFETY OF MED3000, A NOVEL TOPICAL THERAPY FOR THE TREATMENT OF ERECTILE DYSFUNCTION Wayne J. G. Hellstrom, Gerald B. Brock, Arthur L. Burnett, Tim J. Holland, and Ken W. James Wayne J. G. HellstromWayne J. G. Hellstrom , Gerald B. BrockGerald B. Brock , Arthur L. BurnettArthur L. Burnett , Tim J. HollandTim J. Holland , and Ken W. JamesKen W. James View All Author Informationhttps://doi.org/10.1097/01.JU.0001009412.04863.1b.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Oral phosphodiesterase type 5 (PDE5) inhibitors changed the management of erectile dysfunction (ED) for many men, but they are contraindicated in some patients, not tolerated in others, not completely effective, or work too slowly. Consequently, up to 50% of patients cease using a PDE5 inhibitor within one year. Moreover, there is a large untreated population too embarrassed to seek medical treatment. Thus, there is an unmet need for an alternative, effective, fast-acting, first-line, and over-the-counter (OTC) ED treatment with an excellent safety profile. MED3000 is a novel topical non-prescription treatment for ED that has been evaluated in two clinical studies. METHODS: MED3000, a topical gel, was tested on 250 patients in a 12-week, multi-center, randomized, double-blind, parallel-group study (FM57) that included men with a clinical diagnosis of ED for >3 months. Patients or their female partners administered MED3000. In a second multi-center, randomized, open-label, parallel-group study (FM71), MED3000 was compared with 5 mg oral tadalafil over 24 weeks in 96 men with ED. Responder analysis was conducted to assess the percent of subjects meeting or exceeding the minimal clinically important difference (MCID, 4 points) in the International Index of Erectile Function Erectile Function (IIEF-EF) domain per the Rosen criteria. Percent achieving erections in <10 minutes after treatment was also assessed. RESULTS: Approximately 60% of patients using MED3000 achieved clinically meaningful improvements in IIEF-EF domain scores in each of the two studies. In addition, 60.1% and 44.9% achieved erections in <10 minutes in FM57 and FM71, respectively (Table 1). MED3000 was associated with low risk for either local or systemic adverse events (Table 1). CONCLUSIONS: The data from these pivotal studies resulted in the approval of MED3000 in the United States. MED3000 met the MCID for improving erectile function with a favorable safety profile. This novel topical agent may be useful for men with ED who are not candidates for a PDE5 inhibitor, who cannot tolerate adverse events associated with these agents, or who have suboptimal responses to them. The availability of MED3000 OTC may also improve access to safe and effective therapy for an undertreated population. Source of Funding: Futura Medical Developments Limited © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e1074 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Wayne J. G. Hellstrom More articles by this author Gerald B. Brock More articles by this author Arthur L. Burnett More articles by this author Tim J. Holland More articles by this author Ken W. James More articles by this author Expand All Advertisement PDF downloadLoading ...