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| |  Topical Drug Topiglan Effective In More Than Two-Thirds Of Impotence Cases LEXINGTON, MA -- Aug. 26, 1999 -- Investigators from Northwestern University Medical School have reported in the September 1999 Journal of Urology that MacroChem Corp.’s topical drug Topiglan(TM) induced erection in 67 to 75 percent of impotent men tested, versus 17 percent of men receiving a placebo. According to the National Institutes of Health, more than 30 million American men suffer from some degree of impotence, now termed erectile dysfunction by the medical profession. Topiglan treats erectile dysfunction with alprostadil, a naturally-occurring compound that can relax disease-constricted penile blood vessels in impotent men. Before Topiglan, alprostadil had to be injected into the penis with a hypodermic syringe, or inserted into the urethra as a suppository. The Northwestern University team, led by Kevin McVary, MD, associate professor of urology, studied erectile response, skin discomfort and erythema in 48 men with erectile dysfunction secondary to vascular, neurogenic, psychogenic or mixed etiologies in a single-blind, placebo controlled trial. All patients were shown to respond to an injection of alprostadil into the penis. The Northwestern team said it observed no serious adverse effects in the 48 patients in their Topiglan trial, although the majority had skin discomfort. They also reported that blood pressure and heart rate varied minimally. According to MacroChem, one of the important contributions of the Northwestern study to the development of Topiglan was the speculation that the skin irritation might be reduced by applying the drug only to the glans, or head of the penis, rather than to the glans and the shaft. "In a subsequent trial by Dr. Irwin Goldstein and associates at Boston University, Topiglan was applied only to the glans, which reduced skin irritation," explained Paul Schechter, MD, PhD, Vice President of Drug Development and Regulatory Affairs at MacroChem. "In that study, penile erythema was more common with Topiglan than placebo, while symptoms of minor to mild warmth or burning and less commonly, tingling and coolness were reported by most patients following both Topiglan and placebo. No significant changes in vital signs were noted with either treatment.” In the Boston study, efficacy and safety of Topiglan were assessed in a double-blind Phase II office study of 60 patients with moderate to severe erectile dysfunction. During the first visit, patients were screened with placebo gel. Patients who responded to the placebo gel were dropped from the study. At the second visit, remaining patients were randomly allocated to receive either Topiglan or placebo applied to the glans (head) of the penis. These patients were largely in the subgroup having an underlying vascular-disease cause for their erectile dysfunction. Many had failed other pharmacologic treatments. "In these patients with erectile dysfunction, 12 of 31 patients [38.7 percent] treated with Topiglan and only two of 29 [6.9 percent] on placebo achieved an erection judged sufficient for vaginal penetration," Dr. Schechter said. "In a population of patients with moderate to severe dysfunction, many with vascular disease and a history of failure on other treatments, most experts would say those are very good results." Related Links: MacroChem Corp.
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