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| |  Muse Successful in Men With Impotence After Radical Prostatectomy MENLO PARK, Calif. -- April 16, 1997 -- There appears to be hope for men experiencing impotence, or erectile dysfunction, following radical prostatectomy, according to the results of a study with a transurethral suppository, Muse(R) (alprostadil). The findings were presented at the 92nd annual meeting of the American Urological Association in New Orleans. The lead author for the study group, Raymond A. Costabile, MD, from Walter Reed Army Medical Center, said, "The response of patients who developed erectile dysfunction after radical prostatectomy was similar to that of patients with erectile dysfunction derived from other causes, such as vascular disease or diabetes. Our findings suggest that treatment with transurethral alprostadil is effective and well tolerated in these post-surgical patients." In a double-blind, placebo-controlled, multi-center trial, 1,511 patients were evaluated in the clinical setting, and those who were successful in achieving an erection with Muse (alprostadil) were randomized to receive alprostadil or placebo during three months of home therapy. Of the study cohort, 384 patients or 25.4 percent had undergone radical prostatectomy. In the home setting, 57.1 percent of radical prostatectomy patients achieved intercourse at least once compared to 6.6 percent on placebo (p less than 0.001). As with other studies of Muse the most common side effect observed was penile pain, occurring in 39.0 percent of radical prostatectomy patients. In the in-clinic phase of the study, 76.7 percent of patients with more recent surgeries (2-6 months) were able to achieve erections sufficient for intercourse. Patients who had a radical prostatectomy between 7-160 months prior to the in-clinic study achieved erections at a rate of 71.2 percent. Efficacy and safety outcomes were comparable for recent and remote surgery patients. "While patients who had surgery long ago performed well on this therapy, the response of recently prostatectomized men suggests a role for early treatment with transurethral alprostadil," Costabile said. Sudden onset of impotence occurs frequently after surgery in men who undergo radical prostatectomy. Prostatectomy is the surgical removal of the prostate, a procedure performed on patients with prostate cancer when the tumor is localized in the gland. Muse was developed by Vivus, Inc., which pioneered a novel therapy for erectile dysfunction known as the transurethral system for erection. This therapy consists of a proprietary, non-invasive, drug delivery system that delivers pharmacologic agents via the urethra.
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