Spray treatment may prevent premature ejaculation

By Sheilah Downey

Recent trials for an aerosol spray to treat premature ejaculation, a problem more common than erectile dysfunction, has shown promise in the treatment phase, according to results presented at the annual meeting of the Sexual Medicine Society of North America in San Diego.

Results of the double-blind treatment study showed that the aerosol drug, called PSD502, was able to delay ejaculation up to five times longer than those who used placebo, according to a press release.

Patients and partners reported significant improvement in sexual satisfaction and the drug showed little side effects, according to the study results.

Premature ejaculation (PE) is described as "ejaculation occurring within approximately one minute of penetration that causes the patient distress," according to Dr. Stanley E. Althof of the Center for Marital and Sexual Health of South Florida, West Palm Beach.

"Premature ejaculation can have a powerful negative impact on the emotional and sexual lives of men and their partners," said Dr. Althof.
"Now we need to work to develop treatments and these encouraging results with PSD502 seem to be a step in the right direction."

An estimated one-third of men in the United States ages 18 to 59 are affected by PE, making it twice the problem that erectile dysfunction poses.

The three-month trial, which randomized 256 patients in 38 investigational centers in the U.S., Canada and Poland, also assessed safety and tolerability of the therapy. Overall, PSD502 was well tolerated with no serious side effects.

Drug Companies Sciele Pharma, Inc., a Shinogi Company, and Plethora Solutions Limited presented the study at the Society meeting today and representatives said they are planning to submit a drug application PSD502 to the Food and Drug Administration in the first half of 2010.

If approved by the FDA it would be the first prescription treatment for premature ejaculation in the U.S, according to Patrick Fourteau, Chief Executive Officer of Schiele Pahrma, Inc.

"We are excited that results from two pivotal studies have shown that PSD502 was effective for men with PE and we look forward to the opportunity to help patients who have had no real options to date," said Fourteau.