In early 1997, the FDA approved a transurethral delivery system for a urethral suppository containing alprostadil (PGE1), manufactured by Vivus and called the MUSE® 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 the patients on alprostadil reported intercourse compared to only 18.6% of the placebo group. Successful use of MUSE® at home seemed to be equal in all categories of impotence. The consistency of response increased slightly over a period of 3 months. Penile pain occurred in 32.1% of patients receiving the active ingredient (10.8% of all applications). With the MUSE® system, there was minor urethral trauma in 5.1% of the patients. A small subset of patients who used MUSE® reported that previous intracavernosal injection therapy was not effective. Of these, 58% reported erections sufficient for intercourse after MUSE® introduction. Recently, further efficacy studies were performed in a FDA trial of the combination of the MUSE® system with the veno- occlusive band (Actis®). Topical medications have been anecdotally reported and do not produce spectacular results. These include organic nitrates and nitrites, minoxidil, papaverine and PGE1 or PGE2. (C) 2000 Prous Science.
ASJC Scopus subject areas
- Pharmacology (medical)