SAN FRANCISCO—Pivotal clinical trials of a novel treatment for premature ejaculation (PE) have yielded promising results, a researcher announced here at a press conference during the American Urological Association annual meeting.
Called PSD502, the treatment is a topical metered-dose spray containing lidocaine and prilocaine in a proprietary formulation.
“It’s a very important development,” said Ira D. Sharlip, MD, one of the investigators and Clinical Professor of Urology at the University of California-San Francisco.
Dr. Sharlip reported findings from two studies involving a total of 556 men randomized to receive PSD502 or placebo, which was to be applied to the glans penis five minutes before sexual intercourse. Researchers evaluated subjects over three-months in placebo-controlled trials and then over an additional five- to nine-month open-label period. Men in the trials had more than 23,000 exposures to PSD502.
The baseline Intravaginal Ejaculatory Latency Time (IELT) in treatment and placebo arms was 0.6 minutes. At three months, the mean IELT increased significantly to 3.3 minutes in the PSD502 group and nonsignificantly to only 0.9 minutes in the placebo recipients.
PSD502 has a rapid onset of action, which Dr. Sharlip said is an important advantage. The mechanism of action of PSD502 is not known, he said, but it is not related to the numbing effects of lidocaine and prilocaine. Only 1.7% of subjects treated with PSD502 experienced reduced penile sensation during the clinical trials.
Adverse effects (AEs) occurred in 6.1% of men and 6.7% of their partners. In men, the most frequent AE was loss of erection, which occurred in 3.1% of subjects. In the partners, the most frequent AE was burning in the vulvovaginal area, which occurred in 5% of women.
The drug is being developed by Shionogi Pharma, Inc., a U.S.-based group company of Shionogi & Co., Ltd., which has headquarters in Osaka, Japan. The company has not yet submitted an application seeking FDA approval for PSD502.