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| |  SSI: Topiglan Gel More Effective Than Placebo For Erectile Dysfunction BOSTON, MA -- October 5, 1999 -- A topical gel, applied to the head of the penis less than an hour before intercourse, may someday enable millions of impotent men to enjoy satisfying sexual relations, according to research reported Saturday (Oct. 2) at the Society for the Study of Impotence meeting in Boston. In a blinded, randomized trial, the investigational agent known as Topiglan™ proved almost six times more effective than placebo gel in men with vascular-caused erectile dysfunction, the leading cause of male impotence. The study was presented by Irwin Goldstein, MD, Professor of Urology at Boston University School of Medicine, immediate past president of the Society for the Study of Impotence, and one of the nation’s most widely recognized authorities on sexual dysfunction. Topiglan, under development by MacroChem Corporation, is a topical preparation of prostaglandin E1 (alprostadil) and a through-the-skin absorption-enhancing excipient known as SEPA®. Prior to Topiglan, alprostadil could be used to treat erectile dysfunction only if injected deep into the penis with a hypodermic needle, or inserted into the urethra as small suppository, with a syringe-like device. According to the National Institutes of Health, more than 30 million American men suffer some degree of erectile dysfunction (ED). More than half of these men have ED due to vascular disease, like the patients in the Topiglan trial. According to a recent study by the American Association of Retired Persons, fewer than 6 percent of men with ED are currently taking a drug to treat their condition. The Society for the Study of Impotence was established in 1994 as an independent organization of healthcare professionals concerned with human sexual function and dysfunction. Its meeting attracted urologists, researchers and therapists from all over the world.
Details of Phase II Topiglan Study "Sixty men, 97 percent of whom were impotent due to vascular disease, received either a placebo gel or Topiglan, after which their erections were repeatedly observed and measured by a lab nurse - conditions under which many men would find it difficult to produce an erection," Dr. Goldstein said. "No soft lights, no music - not even a partner - and yet, within 45 to 60 minutes of application, almost 40 percent of the impotent men receiving Topiglan produced erections judged sufficient for intercourse, versus less than 7 percent receiving a placebo gel," Dr. Goldstein said. "These patients were difficult cases referred to me by other practitioners. Before being treated with Topiglan, some men in the trial could obtain an erection only with one or more vasodilators injected directly into their penises." According to Dr. Goldstein, side effects were limited to mild penile warmth, in both active and placebo recipients. No significant systemic effects were detected during the trial. No systemic effects were expected, because the body metabolizes 80 percent of any alprostadil that enters the bloodstream in a single pass through the circulatory system. As a result, Topiglan may be especially helpful to patients who cannot take other drugs for erectile dysfunction, because of cardiac conditions or medications. Topiglan is the lead product of MacroChem, a Lexington, MA company specializing in delivering drugs through the skin with SEPA®. MacroChem is currently engaged in discussions with leading pharmaceutical companies in the U.S., Europe and Japan for rights to develop and market Topiglan.
Rigorous Trial Tested Topiglan in Moderate to Severe Erectile Dysfunction During the first visit of the Topiglan trial, patients were screened with a placebo gel. Thirty minutes after gel application, each patient viewed an erotic movie showing heterosexual sex. At 45 minutes, they simulated tactile stimulation with a penile vibrator. They discontinued audiovisual and tactile stimulation at 65 minutes, and were observed until 90 minutes. Any patient who responded to the placebo was dropped from the trial. Non-responders were invited to participate in visit 2. At the second visit, patients were randomized to receive Topiglan or placebo in double-blinded fashion, and the stimulation procedure repeated. At various time points, a nurse assessed angle of erection (measured from the vertical) with a protractor. Patients self-assessed their degree of penile tumescence and rigidity on a 5-point scale, and investigators evaluated signs and symptoms of tolerance. The findings: Topiglan produced a greater angle of erection (p=0.033) and greater maximum rigidity (p=0.003) compared to placebo. Responses to Topiglan were greater than to placebo at all times, with greatest differences at 45 and 60 minutes. 12 of 31 patients (38.7 percent) receiving Topiglan achieved an erection judged sufficient for vaginal penetration vs. 2 of 29 (6.9 percent) on placebo (p<0.005) "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," explained Paul J. Schechter, MD, PhD, Vice President of Drug Development and Regulatory Affairs at MacroChem. "Those findings have a highly statistically significant ‘p-value’ of 0.005 - meaning that the probability that the difference between Topiglan and placebo occurred simply by chance is less than 5 in 1000."
Related Link: MacroChem Corporation.
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