To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Topical Alprox-TD (Alprostadil) Effective For Erectile Dysfunction URL: http://www.pslgroup.com/dg/1E928E.htm Doctor's Guide November 2, 2000
ROBBINSVILLE, NJ -- November 2, 2000 -- A multicenter study, conducted at 12 clinical sites in the U.S., indicated that three different dose levels of Alprox-TD (alprostadil) were shown to be effective in sexual function over placebo as a topical treatment for male erectile dysfunction (ED). The study was randomized, parallel, double-blind, placebo-controlled, and designed to investigate the dose-response relationships of the efficacy and safety of three different doses of Alprox-TD versus a placebo in 161 men with mild to moderate ED. The patients were required to apply up to ten (10) doses at home over a nine-week period and keep a daily diary. The Phase II study results indicated that three different dose levels of Alprox-TD were shown to be effective over placebo in sexual function endpoint analyses, with the highest dose showing a highly significant (p=0.001) increase in Erectile Function Domain scores under the International Index of Erectile Function (IIEF), which is the primary efficacy endpoint for the assessment of ED. The response to the Global Assessment Questionnaire, which measures improvement in erectile function, indicated an efficacy rate of 73 percent in the highest dose group compared to 23 percent in the placebo group. Other secondary efficacy endpoints also showed statistically significant improvements when the highest dose was compared with the placebo. Overall, the vast majority of the side-effects observed in the study were mild in nature and consisted of a transient burning sensation at the application site. The causes of ED, commonly known as impotence, are often age-related. The disease reportedly affects 10 to 20 percent of the male population worldwide. The ED treatment market is projected to grow as the world's population ages. Alprox- TD incorporates alprostadil, an off-patent vasodilator well recognized for treating ED, with the NexACT transdermal penetration enhancing technology. Dr. Y. Joseph Mo, president and chief executive officer of NexMed, commented, "We are extremely encouraged by these U.S. Phase II results which mark an important milestone in our Alprox-TD development program. The Company intends to submit the data in final report form to the FDA for review and concurrence." NexMed, Inc., an emerging pharmaceutical and medical technology company, with a product development pipeline of innovative topical drug treatments based on the NexACT acute transdermal delivery technology. Its two lead NexACT products under development are the Alprox-TD cream treatment for ED and the Femprox cream treatment for female sexual arousal disorder. --------------------------------------------------------------------------------------------- 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.