Ampio Pharmaceuticals, a developer of innovative proprietary drugs for metabolic disease, eye disease, kidney disease, inflammation, sexual dysfunction, and CNS disease, recently provided an update on their drug, ZetaneTM, as well as reported positive news from a meeting with the FDA regarding a clinical trial for its product, OptinaTM.
Ampio announced on September 12, 2012, that it had entered into a definitive agreement with Ethypharm LTD for the manufacturing of its drug for the treatment of premature ejaculation, ZetaneTM. The drug is specifically formulated as an orally disintegrating tablet (NASDAQ:ODT) manufactured by Ethypharm under patented processes jointly owned by Ethypharm and Ampio. Ampio had previously acquired the ODT formulation technology from Valeant back in December of 2011.
Ampiro's agreement with Ethypharm will ensure the conduct of pivotal trials of Zetane™ in the USA as agreed with the FDA. This includes the delivery of the final packaged drug as well as all documentation necessary for registration and approval processes with the FDA and other regulatory agencies, in addition to several other factors (including package registration completion, finalizing pricing, and expanding trials in several additional countries).
In other recent news, the company announced that it had successfully held a pre-IND meeting with the FDA's ophthalmology division of the Center for Drug Evaluation and Research (CDER). The meeting took place on July 31, 2012, and was sought by Ampiro to gain guidance for a clinical trial path for its product, OptinaTM. The FDA approved the current trial pathway, raising no safety or CMC concerns, and agreed that no additional non-clinical studies were necessary.
Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, stated, "We are now able to launch a larger study using visual acuity rather than Optical Coherence Tomography (OCT) as the measure of efficacy and we are able to adjust the dosage to body mass index (NYSE:BMI) to achieve the optimal benefit. We are pleased that the injectable drug Lucentis™ is likely to be approved and made available to the underserved DME patients. We believe Optina™ may provide additional advantages to these patients, as Optina™ is administered orally and is based on a very low dose of a previously approved drug, danazol. Extensive clinical experience with the drug has allowed the FDA to permit Ampio to use the 505(b)2 path for drug registration. The 505(b)2 is a significantly shorter and less expensive path than those of new chemical entities. There is an obvious advantage to an oral drug vs. one that requires injection directly into the eye. Complications such as eye infection, increased intra ocular pressure (IOP) and local eye irritation reported in the Lucentis™ studies are NOT a concern for Optina™."
For more information on Ampio Pharmaceuticals, visit www.ampiopharma.com
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