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| |  New Drug Treatment Helps Restore Sexual Function MADISON, Wis., June 11, 1996 -- As many as two-thirds of men who experience erectile dysfunction (impotence) due to physical causes, like diabetes and the after effects of prostate surgery, may benefit from a yet-to-be approved drug therapy that is less invasive and more discreet than other therapies, according to results of a major new study. The study, conducted at the University of Wisconsin Medical School and 57 other centers across the country, found that the therapy, transurethral alprostadil (brand name MUSE(R) alprostadil), enabled 64.9 percent of men with erectile dysfunction to achieve sexual intercourse compared to 18.6 percent who were on placebo (p0.001). Most of the men required treatment because of surgery or trauma, vascular disease or diabetes. The study is the largest double-blind, placebo-controlled study to date on erectile dysfunction. Dr. Wolfram E. Nolten, University of Wisconsin Medical School associate professor of medicine and an endocrinologist and andrologist at UW Hospital and Clinics, presented findings today at the 10th International Congress of Endocrinology, which is meeting in San Francisco. Recently, study data were also presented at the annual meeting of the American Diabetes Association. "This therapy represents an effective and safe treatment option that is discreet and easy to administer, and thus is sensitive to couples' needs," said Nolten. He added that the therapy doesn't lead to fibrosis (anatomical changes in the male organ) or unduly persistent erections, as other therapies may. About 20 million men in the United States have erectile dysfunction, defined as the inability to achieve or maintain an erection. The problem is usually caused by vascular or neurological abnormalities, including diabetes, and can result from prostate surgery. Between 50 and 60 percent of diabetic men over age 50 have erectile dysfunction. Current treatments consist of penile prosthetic implants, use of vacuum devices or needle injection of vasoactive substances into the penis, including alprostadil (prostaglandin E1), a medication which increases penile blood flow. MUSE(R) is a polypropylene applicator that delivers alprostadil to the urethra. Following urination, the applicator is inserted gently into the urethra. The applicator contains a mico-pellet of alprostadil. By pressing the button at the end of the applicator, the pellet is deposited onto the urethral lining where the medication is quickly absorbed and produces an erection in about 10 minutes. Nearly 1,000 men participated in the study, conducted in the privacy of their homes. On average, participants had had erectile dysfunction for four years. Among those who responded to therapy, nearly seven out of every 10 applications resulted in sexual intercourse. The most common side effect, minor penile pain, occurred in 10.9 percent of participants, but rarely resulted in their discontinuing the study. The company developing MUSE(R), VIVUS, Inc., recently filed a New Drug Application with the U.S. Food and Drug Administration, a required step in making the treatment available to patients. "I am very encouraged by these results, which promise a minimally invasive and very effective new therapeutic option that is acceptable to the patient, and will also result in improving the quality of life for both patient and partner," said Nolten.
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