EU trial
BANGALORE (Reuters) - Ampio Pharmaceuticals Inc. announced its drug to treat ejaculation showed statistically significant results in a late trial in Europe.
The drug, called Zertane, is regarded as needed before sexual activity and is not necessary to be taken on a daily basis.
Ampio said "the analysis of the results of the trial has exceeded our expectations." The company expects that the results of this test will allow the file to European regulatory approval for the drug. In his statement today, the company did not plans to market Zertane to the United States.
The active ingredient in Zertane is hydrocloride tramadol, which has been used to relieve the pain since the mid-1990s. Ampio specializes in "repositioning" drugs, i.e. testing of already approved drugs to find treatments for new indications.
Ampio said in a statement that ejaculation is the most common male sexual dysfunction, including about 23% of all men aged 18 to 75 years.
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