Researchers have announced a second positive trial of an aerosol spray medication, termed PSD502, used to treat premature ejaculation (PE).
PE is defined as a male sexual dysfunction characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration.
Premature ejaculation has a host of negative personal consequences for both partners ranging from distress to frustration or the avoidance of sexual intimacy.
Results of the double-blind treatment phase of the study showed that men who were treated with the drug five minutes before intercourse were able to delay ejaculation up to five times longer than those who used placebo.
Additionally, patients and partners in both trials reported significant improvements in sexual satisfaction, and the drug was well tolerated.
An estimated one-third of U.S. men ages 18-59 are affected by PE, making it twice as prevalent as erectile dysfunction. Currently, there are no prescription therapies approved in the U.S. to treat PE.
“Premature ejaculation can have a powerful negative impact on the emotional and sexual lives of men and their partners,” said Professor Stanley E. Althof, PhD, Center for Marital and Sexual Health of South Florida, West Palm Beach, Florida.
“Recently, the international sexual health community agreed that PE should be defined as ejaculation occurring within approximately one minute of penetration that causes the patient distress. Now we need to work to develop treatments, and these encouraging results with PSD502 seem to be a step in the right direction.”
Both trials showed clinically and statistically significant efficacy in the treatment of premature ejaculation, as measured by changes in Intravaginal Ejaculatory Latency Time (IELT) and Index of Premature Ejaculation (IPE), a patient-reported outcome of ejaculatory control, sexual satisfaction, and distress.
“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 Patrick Fourteau, Chief Executive Officer of Sciele Pharma, Inc.
“This data will support the New Drug Application for PSD502 that we are planning to submit to the U.S. Food & Drug Administration (FDA), which upon FDA approval would make PSD502 be the first prescription treatment in the U.S. for premature ejaculation.”