Ampio Pharmaceuticals reported positive data from a Phase III study evaluating its premature ejaculation candidate Zertane™ in 604 patients. Results from the European trial showed that the lower of two Zertane doses increased the median intravaginal ejaculatory latency time (IELT) by a mean of 4.07 over baseline, and by a geometric mean of 2.3-fold over baseline. The higher dose of Zertane increased mean IELT by 4.26 over baseline, with a geometric mean increase of 2.4-fold over baseline.
Among men with a median IELT of 1 minute or less at baseline, the results were even more significant. Mean IELT increases were 5.2-fold for the lower dose of Zertane and 6-fold for the higher dose. “We are aggressively pursuing regulatory approval for Zertane in Europe and are in discussions with potential distribution partners in Europe and Asia,” comments Don Wingerter, CEO.
The firm says no drug has yet been approved in the U.S. specifically for the treatment of premature ejaculation, and clinical data comparisons indicate that Zertane is more effective than dapoxetine (Priligy®), an SSRI antidepressant-type drug that is the only oral drug approved anywhere for the treatment of premature ejaculation.