Intraurethral and topical agents

In early 1997, the FDA approved a transurethral delivery system for a ureth ral suppository containing alprostadil (PGE(1)), manufactured by Vivus and called the MUSE(R) system. Pharmacokinetic studies showed rapid absorption from the urethra (80%) in the first 10 minutes after an intraurethral dose. 873 patients tried home use of alprostadil or blinded placebos. 64.9% of t he patients on alprostadil reported intercourse compared to only 18.6% of t he placebo group. Successful use of MUSE(R) at home seemed to be equal in a ll categories of impotence. The consistency of response increased slightly over a period of 3 months. Penile pain occurred in 32.1% of patients receiv ing the active ingredient (10.8% of all applications). With the MUSE(R) sys tem, there was minor urethral trauma in 5.1% of the patients. A small subse t of patients who used MUSE(R) reported that previous intracavernosal injec tion therapy was not effective. Of these, 58% reported erections sufficient for intercourse after MUSE(R) introduction. Recently, further efficacy stu dies were performed in a FDA trial of the combination of the MUSE(R) system with the veno-occlusive band (Actis(R)). Topical medications have been ane cdotally reported and do not produce spectacular results. These include org anic nitrates and nitrites, minoxidil, papaverine and PGE(1) or PGE(2). (C) 2000 Prous Science. All rights reserved.