PE as topical as ED

Published: 23-Jul-2003

NexMed, a developer of innovative transdermal treatments based on its NexACT proprietary drug delivery technology, has reported progress in the development of a NexACT-based topical treatment for premature ejaculation (PE), a condition commonly recognised as the most prevalent form of male sexual dysfunction.


NexMed, a developer of innovative transdermal treatments based on its NexACT proprietary drug delivery technology, has reported progress in the development of a NexACT-based topical treatment for premature ejaculation (PE), a condition commonly recognised as the most prevalent form of male sexual dysfunction.

According to Medical Aspects of Human Sexuality (May 2001), as many as one-third of all sexually active men suffer from PE. However, less than 10% of these patients seek treatment due to embarrassment or lack of effective treatment.

NexMed conducted a three-month, multi-center, single-blind pilot study for which fifty-one PE patients (mean age 37.7 years and PE duration of 4.5 years) were recruited. Eight patients were enrolled in the control (alprostadil) cream group and 43 patients were enrolled in the study (alprostadil/lidocaine/NexACT) cream group. The primary efficacy variable was ejaculatory latency time (ELT). The secondary efficacies include the degree of satisfaction of both patient and partner, as well as physician assessment of clinical efficacy.

In the control group, only 12.5% patients, after administration of the cream, had a mean ELT over 2 minutes, and no satisfaction was reported from either patients or their partners. In the alprostadil/ lidocaine/ NexACT cream treatment group, the ELT increased to more than two minutes in 53.5% of all patients. The sexual satisfaction, as assessed by the patients and their partners, reached 72.1% and 67.4%, respectively. The clinical efficacy was 72.1% as assessed by the doctors. All reported adverse events were mild and transient.

NexMed recently completed a second proof of concept study, which was a multi-center, double-blind, crossover, at-home use trial. The data are currently being reviewed and analysed. Both studies were conducted overseas.

Dr Ming Qi Lu, NexMed's director of exploratory development, commented: 'The results from the two studies suggest that our proprietary product under development has the potential to become an effective treatment for PE. We look forward to undertaking additional development of this product in the US and abroad.'

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