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| |  New Drug Combination Effective Against Impotence MENLO PARK, Calif. -- April 14, 1997 -- The results from clinical studies of two new products show the combination of alprostadil/prazosinis an effective treatment for impotence . During presentations made at the 92nd annual meeting of the American Urological Association in New Orleans, results were reported from one study of a combination of the drugs alprostadil and prazosin delivered via the novel transurethral route pioneered by Vivus, and another study of a venous flow control device Vivus is now marketing under the brand name Actis. Transurethral combination delivery of alprostadil/prazosin Clinicians presented findings from a double-blind, multi-center trial of 415 patients with chronic erectile dysfunction designed to evaluate the benefit of adding prazosin to transurethral therapy with alprostadil. Alprostadil, a synthetic version of prostaglandin E1, is a vasodilator that relaxes the smooth muscle in the penis allowing increased blood flow. Prazosin is an alpha-blocking agent that contributes to an erection by blocking smooth muscle contraction. Each of the nine alprostadil/prazosin combinations produced higher rates of intercourse than did the respective dosages of alprostadil alone. In six of the nine combinations, the higher rates were statistically significant compared to alprostadil alone. Overall, 68 percent of patients reported successful intercourse. All study patients had complete, organic erectile dysfunction. Observed side effects included penile pain (7.6 to 19.8 percent of administrations) and hypotension (1.5 to 9.2 percent of administrations). Hypotension was most commonly seen at the higher combination doses. The most promising one or two doses, those with highest efficacy and lowest side effects, will be advanced to Phase III study and product development. "Combination drug therapy has been shown to be useful in injection therapy previously, but this is the first demonstration of the value of pharmaceutical combinations in transurethral therapy,” said Ronald W. Lewis, M.D., professor and chief of urology from the Medical College of Georgia, Presenting on behalf of the Vivus-Muse Study Group of 23 institutions. “The combination of prazosin with alprostadil was significantly more effective in helping men with chronic erectile dysfunction achieve sexual intercourse." Actis venous flow controller for veno-occlusive dysfunction Investigators at UCSF, USC and Vivus, Inc. reported on a pilot study of eight patients, previously unresponsive to Muse(alprostadil), who employed the Actis venous flow controller followed by transurethral administration of Muse (alprostadil) 500 mcg. Penile rigidity and duration of erection were measured and compared to results achieved by the same patients administered transurethral alprostadil alone on a separate day. Six of the eight patients, previously unresponsive to Muse alone, were able to achieve an erection sufficient for intercourse by using Muse plus the Actis device. Mean penile rigidity increased with Muse plus Actis compared with Muse alone (p=0.02). The mean duration of intercourse also increased significantly from approximately 1.3 to 14.0 minutes (p=0.01). "This simple device boosts the effect of transurethral alprostadil and permits many previously unresponsive men to be successfully treated with Muse," said Sherif R.G. Aboseif, M.D., assistant professor, Department of Urology at UCSF, who presented for the investigational group Actis venous flow controller is a device designed for patients suffering from veno-occlusive dysfunction or venous leak syndrome. Patients with this disorder are unable to sustain an erection because sufficient blood cannot be kept in the penis to maintain rigidity. Actis is an easy-to-use, fully adjustable external penile band that is placed around the base of the penis, allowing the patient to limit venous outflow while permitting arterial inflow necessary for an erection. The product was approved by the United States Food and Drug Administration (FDA) in December 1996. Actis is currently undergoing clinical study exploring its use with Muse(alprostadil) in a multi-center trial. The study, slated to enroll approximately 400 patients, is designed to assess the impact of drug/device combination therapy in patients with erectile dysfunction. Founded in 1991, Vivus, Inc. develops advanced therapeutic systems for the treatment of erectile dysfunction.
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