FDA announces guidance for licensing Zertane (Ampio Pharma) for Premature Ejaculation

Ampio Pharma has announced the outcome of its pre-IND meeting with the FDA to discuss the licensing of Zertane (oral rapidly dissolving tramadol) for Premature Ejaculation. The FDA provided guidance on the design of two Phase III pivotal clinical trials of approximately 15 weeks duration. Successful completion of these trials will allow for FDA clearance to market Zertane as a treatment for life-long Premature Ejaculation. 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.