To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: AUA MEETING: Study Shows Long-Term Safety of Muse For Impotence URL: http://www.pslgroup.com/dg/81ADA.htm Doctor's Guide June 2, 1998
MOUNTAIN VIEW, CA -- June 2, 1998 -- With the treatment of impotence becoming an everyday topic of discussion, talk is now turning to a key aspect of treatment -- safety. Data presented today at the American Urological Association (AUA) meeting in San Diego from a large clinical trial program of Vivus' Muse(R) (alprostadil), a treatment for erectile dysfunction, show that Muse demonstrated long-term safety (in excess of 24 months) with regard to drug-related and/or serious adverse effects. Muse was evaluated in 2,591 men with moderate to severe, organic erectile dysfunction in trials throughout the United States and Europe and was shown to be well-tolerated with a favourable long-term safety profile. "This study confirms earlier findings that Muse is a safe product," said Dr. Richard Labasky, lead investigator of the study and assistant professor of surgery at the University of Utah School of Medicine in Salt Lake City, UT. "What's noteworthy is we've been able to follow patients who have been using Muse for more than two years and the safety profile has remained very consistent. "This study group included men after prostate surgery as well as those with severe vascular disease and diabetes, which highlights the safety of this drug in an organic dysfunction population." Muse has been used by more than 600,000 men in the U.S. since January 1997. Muse, the first and only transurethral delivery system for erectile dysfunction, is based on the discovery that the urethra can absorb certain medications. Because Muse is administered locally, it minimises potential systemic side-effects and drug interactions. In placebo-controlled trials of Muse, hypotension, dizziness and syncope occurred in three percent, four percent and 0.4 percent, respectively, of patients during in-clinic titration and alprostadil-related side effects with home therapy included penile pain, occurring in approximately 30 percent of patients. Treatment with Muse resulted in a minimal serious adverse event rate similar to treatment with placebo. Muse did not increase the incidence of heart attack, stroke, hospitalisation, disability or death. "Significant clinical experience has been gathered using Muse," Dr. Labasky said. "The drug is well-tolerated and has a favourable long-term safety profile in patients with underlying organic conditions undergoing therapy for erectile dysfunction." In addition to the Muse safety data released today at AUA, Vivus is presenting abstracts on two investigational therapies for erectile dysfunction. One study discusses the efficacy of Muse in conjunction with the Actis(R) adjustable penile constriction band. The study, which was led by Ronald Lewis, M.D., shows that the combination of Muse and Actis may augment the drug effect (of Muse alone) and is an effective, non-invasive method to restore sexual function in the majority of men with erectile dysfunction. Another study focused on a new transurethral bi-mix, Alibra, consisting of transurethral alprostadil and the alpha blocker prazosin, shown in preliminary studies to be effective in men with erectile dysfunction. This study, which was led by Raymond Costabile, M.D., shows that the combination of alprostadil/prazosin resulted in successful sexual intercourse in a significant number of men unresponsive to alprostadil alone. More information on: Muse and Vivus --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.