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Pivotal Data for the Investigational Treatment PSD502 for Primary Premature Ejaculation in the United States to be Presented at Major Medical Meeting
Date:6/1/2010

n the definition used, ranges from 5% to more than 30% incidence of PE or ejaculatory control issues have been reported in the literature. For example, according to a large national study, approximately 30% of men suffer from ejaculatory control issues, including climaxing too early, while data from the National Health and Social Life Survey (NHSLS) states the prevalence as 21% in men ages 18 to 59 in the United States.

Pivotal Study Details

Men selected from 70 centers in the United States, Canada and Europe with primary PE and an Intravaginal Ejaculatory Latency Time (IELT) of less than one minute were randomly placed in one of two groups, two-thirds in the PSD502 group and one-third in the placebo group. Participants were instructed to apply PSD502 or placebo to the glans penis five minutes before intercourse. Efficacy was assessed by changes in IELT and in the domains of the Index of Premature Ejaculation (IPE), a patient reported outcome questionnaire, over a period of three months.

The baseline IELT in both study groups was less than 0.6 minutes which increased 5.5 fold and 1.6 fold in the PSD502 and placebo groups, respectively (p<0.0001), resulting in a mean IELT of 3.3 minutes in the PSD502 group. There were greater improvements in all domain scores of the IPE in the PSD502 group compared to placebo resulting in 6.0, 5.3 and 2.6 point differences between PSD502 and placebo in ejaculatory control, satisfaction and distress domains respectively (p<0.0001 for all).

In the PSD502 group, 6.1% of patients reported treatment-related adverse events versus 0.6% in the placebo group.  There was one treatment-related adverse event greater than or equal to 3% (loss of erection; 3.1%).  Al
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SOURCE Shionogi Pharma, Inc.
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