To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: MacroChem Accelerates Development of Topical Gel For Impotence URL: http://www.pslgroup.com/dg/237FA.htm Doctor's Guide April 10, 1997
LEXINGTON, Mass., April 10, 1997 -- MacroChem Corporation today announced that it is accelerating the product development program of a topical gel containing alprostadil and Sepa(R), for the treatment of erectile dysfunction (impotence). This decision is based on the promising results of the ongoing Phase I/II study. Sepa, MacroChem's proprietary compound, enhances the delivery of drugs through human skin and into the bloodstream. The study was conducted by Kevin McVary, M.D. at Northwestern University Irwin Goldstein, M.D., Professor of Urology at the Boston University School of Medicine, will assist with the scientific and clinical direction of the program. He specializes in the research, diagnosis and treatment of erectile dysfunction, and has published over 150 scientific papers in this area. Dr. Goldstein played a role in the investigation and development of other products for the treatment of erectile dysfunction including Pharmacia & Upjohn's Caverject(R), Pfizer's Viagra(R) and Zonagen's Vasomax(R). MacroChem also announced the appointment of David Ferguson, Ph.D., M.D. as a consultant in clinical development project management. Dr. Ferguson has been involved in pharmaceutical development for 29 years and contributed to 11 successful New Drug Application (NDA) approvals. Since 1992, he has been intimately involved with the design and implementation of clinical programs for urological products, particularly erectile dysfunction. Commenting on the prospects of Sepa/alprostadil, Dr. Ferguson said, if successful, the development of a topical gel alprostadil would have a major impact on this market, as it would be the only drug approved for this indication that would not entail direct injection into the penis (Upjohn's Caverject), or the insertion of a device into the urethra (Vivus' Muse(R)). "Undoubtedly, patients will find a topical gel friendlier to use," he said. He added that currently, impotence affects more than 50% of men over 40 years of age. The next step in the program will be a Phase IIB dose response study to be conducted by Dr. Goldstein. --------------------------------------------------------------------------------------------- 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.