Robbinsville, NJ, May 23, 2005--NexMed, Inc. (Nasdaq: NEXM), a developer of innovative transdermal treatments based on its proprietary NexACT® drug delivery technology, today announced the preliminary results from a 400 patient "at home" study conducted in China. The multi-center study was randomized, double-blind, placebo-controlled, and designed to investigate the efficacy and safety of three strengths of the Femprox® cream in pre-menopausal and post-menopausal women diagnosed with female sexual arousal disorder ("FSAD"). Femprox is applied topically and incorporates alprostadil, a vasodilator, with the NexACT® permeation technology. The results were announced at the Annual Meeting of the American Urological Association (AUA), Tuesday, May 21-26, 2005, in San Antonio, TX.
The patients, who were between the ages of 21 and 65, were randomly assigned to placebo or one of three strengths of Femprox. They were required to use one application of Femprox prior to engaging in sexual activity, up to ten times during two treatment evaluation periods. The primary efficacy end point was the arousal success rate determined by the internationally recognized Female Sexual Encounter Profile (FSEP) questionnaire. Secondary efficacy end points included changes in the Female Sexual Function Index (FSFI), in other FSEP responses, and in the Female Sexual Distress Scale (FSDS), as well as the Global Assessment Question (GAQ).
The primary efficacy endpoint was statistically significant at the end of both evaluation periods. Patients showed demonstrable improvement in sexual arousal over the course of therapy. At the end of the first evaluation period, 17% and 38.7% (p<0.001) improvement in mean arousal success rate from baseline were reported for placebo and the highest dose of Femprox, respectively. At the end of the second evaluation period, 28.6% and 51.5% (p<0.001) improvement were reported for placebo and the highest dose of Femprox, respectively.
All of the secondary efficacy criteria showed a consistent trend in support of the primary efficacy results, including a demonstrated positive patient satisfaction by the GAQ. A total of 372 patients completed the study. The side effects reported were mostly mild or moderate in intensity, reversible and short in duration.
Dr. Joseph Mo, NexMed's C.E.O. commented, "NexMed has reached another major milestone in the Femprox development program. We have completed one of the first large scale take-home studies for a topical FSAD treatment." Dr. Mo further added, "We will complete the analysis of the data and submit the results to the regulatory authorities in China and in the U.S. for review and comment. We also intend to share these results with potential partners who have expressed an interest in co-developing the product with us in the U.S."
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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