ROBBINSVILLE, NJ -- June 4, 2001 -- NexMed, Inc., a developer of innovative treatments for sexual dysfunction, presented clinical results for a Phase II study of the Alprox-TD® cream treatment (alprostadil transdermal) for erectile dysfunction ("ED") in 142 patients with severe ED. The results were presented today at the Annual Meeting of the American Urological Association (AUA) in Anaheim, California.
Using a Global Assessment Questionnaire as a measurement of their satisfaction with treatment, patients reported improvement in their erections of 83 percent, 76 percent and 59 percent in the High, Medium and Low dose groups, respectively, versus 26 percent in the placebo group. The Phase II study was randomized, double-blind, placebo-controlled, and designed to investigate the efficacy and safety of three different doses of Alprox-TD in 142 men between the ages of 29 and 70, diagnosed with severe ED.
During the six-week test period, the patients were required to undergo ten at-home applications of Alprox-TD and attempt intercourse after each application. All of the patients maintained a diary.
The study results suggested a linear dose response trend of high significance (p=0.009) as determined by the change in the EF (Erectile Function) domain scores of the IIEF (International Index of Erectile Function). The IIEF is the standardized scale to measure degree of EF in males.
Following six weeks of therapy, the changes in the EF scores were 9.4, 6.5 and 6.3 for the High, Medium and Low dose groups, respectively, in comparison to a change of 2.7 for the placebo treatment group. The change in score of 6.7 between the High dose (9.4) and the placebo (2.7) groups is considered to be highly clinically relevant. The side-effects observed in the study were mostly mild to moderate in nature and short in duration.
Overall, the treatment was well tolerated.
alprostadil, an off-patent vasodilator drug well recognized for the treatment
of ED, with the Company's patented NexACT® transdermal drug delivery
technology. Alprox-TD is packaged in the Company's proprietary single-dose
dispenser, which is convenient and easy to use. The pre-measured dose is
applied locally to the tip of the penis with the onset
of activity reported at 10-15 minutes as compared to 45-60 minutes for the approved oral ED medication.
Dr. James Yeager, the Company's Vice-President for R&D commented, "To date, we have tested over 300 patients in our U.S. Phase II clinical development program for Alprox-TD. The excellent results from this study confirm the data from our first study, which enrolled 161 patients with mild to moderate ED. Both sets of data indicate a similar pattern of efficacy and safety of Alprox-TD versus placebo in sexual function endpoint analyses." Dr. Yeager added, "The FDA is currently reviewing the study results. Pending its concurrence, we intend to begin our Phase III trials for Alprox-TD which are designed to enroll 2,500 ED patients at 80 sites in the U.S."
SOURCE: NexMed, Inc.