The trial demonstrated that in patients who received PSD502, 91% achieved an IELT of greater than one minute and 75% achieved an IELT of greater than two minutes following treatment, as compared to 54% and 22% of placebo patients, respectively. The study also assessed the safety and tolerability of the therapy.
The results showed that men treated with PSD502, five minutes before intercourse, were able to delay ejaculation up to six times longer than those who used a placebo.
The clinical trial was conducted with 300 randomized patients across 32 investigational centers in four countries across Europe. Of these, 268 patients have now been entered into the optional nine-month open label study.
Ed Schutter, President and COO, Sciele, said: “PSD502 may represent a promising new therapy in the management of premature ejaculation, meeting an unmet medical need in a condition that affects millions of men.”