Ampio Pharmaceuticals Inc said its drug to treat premature ejaculation showed statistically significant results in a late-stage trial in Europe.
The drug, called Zertane, is taken as needed before sexual activity and is not required to be taken on a daily basis.
Ampio said "the analysis of the trial results exceeded our expectations." The company expects the data from this trial will allow it to file for European regulatory approval for the drug. In its statement today, the company did not mention plans to market Zertane in the U.S.
The active ingredient in Zertane is tramadol hydrocloride, which has been used for pain relief since the mid-1990s. Ampio specializes in "repositioning" drugs, that is, in testing previously approved drugs to find treatments for new indications.
Ampio said in a statement that premature ejaculation is the most common male sexual dysfunction, afflicting about 23 percent of all men between the ages of 18 and 75 years old.