PSD502 spray may help men perform better in bed

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Men who used PSD502 were able to maintain an erection 5.5 times longer than men who used the placebo spray (1.6 times), a significant difference between the groups.



In two remarkable studies, a new investigational drug showed promise in curing men's premature ejaculation (PE), an often embarrassing problem for men that can lead to serious relationship problems.



Shionogi Pharma, Inc., a U.S.-based group company of Shionogi & Co., Ltd., has developed a spray medication, PSD502, for the treatment of primary premature ejaculation (PE).

Currently, there are no prescription therapies approved by the Food and Drug Administration to treat this condition. But the U.S. company Shionogi Pharma thinks it has found an answer to make men perform better in bed.

Study details
The investigational topical metered dose spray of the drug PSD502 can significantly improves the time to ejaculation in men experience PE, results of two new studies show.

For the studies, researchers studied 1,000 men who had premature ejaculation in the United States, Canada and Europe over a three-month period.

Currently, there are no prescription therapies approved by the Food and Drug Administration to treat this condition. But the U.S. company Shionogi Pharma thinks it has found an answer to make men perform better in bed.

Two-thirds of the participants were prescribed the active spray PSD502, containing the anesthetics lidocaine and prilocaine and one-third were given the placebo spray, lacking both active ingredients.

The spray was applied to the glans penis five minutes before sex via a metered dose.

Findings


More precisely, men who used PSD502 were able to maintain an erection 5.5 times longer than men who used the placebo spray (1.6 times), a significant difference between the groups.



Side effects
Nearly 6 percent of patients who used PSD502 reported treatment-related adverse effects (AEs) as compared to 0.6 percent of men in the control group. AEs occurred in 6.7 percent of those whose partners used PSD502.

Five percent of the men's sexual partners reported burning in the vulvovaginal area, while in men the most frequent AE was loss of erection, which occurred in 3.1 percent of subjects.

"Combined results from the PSD502 pivotal studies are very exciting, and this is a significant milestone," said Ira D. Sharlip, M.D., clinical trial investigator and clinical professor of urology at the University of California, San Francisco.

Results of two studies were presented to the 2010 American Urological Association Annual Meeting in San Francisco.

Premature ejaculation
Premature ejaculation, also known as rapid ejaculation, early ejaculation, or by the Latin term ejaculatio praecox, is the most common sexual problem in men, characterized by a lack of voluntary control over ejaculation. It is the main cause for distress in a relationship.

According to the International Society for Sexual Medicine, premature ejaculation is defined as 'a male dysfunction characterized by ejaculation which always occurs prior to or within about one minute of vaginal penetration; and, inability to delay ejaculation on all or nearly all vaginal penetrations; and, negative personal consequences, such as distress, bother, frustration and or the avoidance of sexual intimacy'.

Health experts estimate as many as one-third of American men aged 18 to 59 years are affected by the problem caused by a complex interaction of biological and psychological factors.

Besides biological reasons like inefficient thyroid gland, prostrate infection, hormonal problems, changes in the brain chemicals level, abnormal reflex in the ejaculatory system and inherited traits, psychological factors like stress, feeling anxious about rejection and negative sexual experiences in childhood can result in a dissatisfying sexual encounter.

Additional information:

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