Ampio (AMPE) Reaches Agreement for Zertane CTD Preparation in Australia
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Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE) has reached an agreement with the Therapeutic Goods Administration (TGA), Canberra, Australia, on a plan of drug manufacture and quality control for Zertane™ and the overall plan for the preparation of Common Technical Documents for the draft registration submission expected to be filed in June 2012.
Michael Macaluso, Ampio's CEO noted, "Zertane, the company's repurposed medication, low dose Tramadol, designed for the treatment of Premature Ejaculation (PE) 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."
Michael Macaluso, Ampio's CEO noted, "Zertane, the company's repurposed medication, low dose Tramadol, designed for the treatment of Premature Ejaculation (PE) 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."
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