Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) ("Ampio" or the "Company"), a company that discovers and develops new uses for previously approved drugs and new molecular entities ("NMEs"), announced today that it reached 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."
Mr. Macaluso further noted, "The only alternative medication for PE, Johnson and Johnson's Priligy™ is already approved in Australia. Registration of Zertane™ in Australia will not only open up the Australian market but assist the regulatory process in other countries, such as Korea and Brazil where the company has existing licensing agreements."
Vaughan Clift, MD, Ampio's Chief Regulatory Officer, added, "In parallel to preparing the submission document, the company will begin production of the initial product runs and quality testing, which are necessary for the full submission document to be filed and the company does not believe, at this stage, that any further clinical or preclinical trials will need to be conducted to support the submission."
SOURCE Ampio Pharmaceuticals, Inc.