Ampio Pharma to discuss filing with FDA of Zertane for Premature Ejaculation treatment

Ampio Pharma has submitted to the FDA a pre IND package on Zertane (oral rapidly dissolving tramadol), its on-demand Premature Ejaculation drug, for a meeting and discussion on the way forward. Zertane has successfully completed two phase II and two phase III studies in Europe that met all end points including efficacy and safety. A follow on 12 weeks open label study of 101 patients demonstrated no abuse potential or dependency.