Washington, June 1 (IANS) Patients of premature ejaculation (PE), treated with PSD502, a metered dose spray five minutes before sex, could perform 5.5 times longer than those who used a placebo spray.
The finding is based on an evaluation of a combined total of 556 (randomised) and 536 (treated) men with primary PE in the US, Canada and Europe over a three-month period, with more than 23,000 recorded exposures to PSD502.
‘Combined results from the PSD502 pivotal studies are very exciting and this is a significant milestone,’ said Ira D. Sharlip, clinical trial investigator and clinical professor of urology at the University of California, San Francisco (UCSF).
The exact incidence of PE is not known, as a widely accepted definition of PE has only recently become available.
For example, according to a large national study, approximately 30 percent 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 percent in men aged 18 to 59 in the US.
Men selected from 70 centres in the US, Canada and Europe with primary PE who ejaculated in less than a minute of vaginal sex, 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 from changes in ejaculation time and in the domains of the Index of Premature Ejaculation (IPE), a patient reported in questionnaire over a period of three months.
The baseline 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, resulting in a mean performance of 3.3 minutes in the PSD502 group.
A male sexual dysfunction is characterised by ejaculation which always or nearly always occurs prior to or within one minute of vaginal penetration; and inability to delay ejaculation on all or nearly all vaginal penetrations.
And this often leads to negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy. Currently, there are no prescription therapies approved by the US Food and Drug Administration to treat premature ejaculation.
PSD502 is a proprietary formulation of the two marketed drugs lidocaine and prilocaine dispensed as a topical metered dose spray that is currently under investigation for the treatment of primary PE, said an UCSF release.
