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news.Ampio Pharmaceuticals has concluded data analysis of multi-center, double-blind, placebo-controlled design Phase III European clinical trials of Zertane, a repurposed drug indicated for the treatment of premature ejaculation (PE).
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The data demonstrated statistical prominence in every category analyzed, with only very minor and minimal adverse events.
The study involved around 604 intent-to-treat patients.
On the basis of this data, Ampio expects to file a comprehensive application to selected European regulatory agencies to seek approval for commercialization of Zertane.
Ampio founder and chief scientific officer David Bar-Or said completion of the Phase Three trials was particularly significant in that only about 15% of drugs that enter this phase have a successful outcome.
Ampio CEO Donald Wingerter said in the near future, Ampio will provide a presentation of the trial results that will include comparisons to published data on the only other PE drug currently marketed in Europe as well as their commercial strategic plan for this product.