Ampio Reports Successful Type B Pre-IND Meeting with the FDA for its Drug Zertane™ to treat Premature Ejaculation (PE)
06/21/2012 | Press Release
GREENWOOD VILLAGE, Colo., June 21, 2012 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (AMPE), a clinical stage biopharmaceutical company, with repurposed drugs and new molecular entities (NMEs) that treat inflammatory diseases, including osteoarthritis, diabetic macular edema (DME) and sexual dysfunction announced today the outcome of its pre-IND meeting with the CDER Urology and Reproductive group (DRUP) division of the FDA that took place on June 20, 2012. The FDA provided all the necessary guidance on the design and conduct of two concurrent phase III pivotal clinical trials of approximately 15 weeks duration. Successful completion of these trials, powered adequately (based on the phase 3 European trials), will allow for FDA clearance to market Zertane™ as a treatment for life-long premature ejaculation (PE) as defined by the International Society of Sexual Medicine. These clinical trials would qualify Zertane™'s registration/clearance under the 505(b) 2 regulatory pathway in the US.
Michael Macaluso, Ampio's CEO, noted, "We could not be more pleased, as the FDA guidance gave us a clear path to progress our Zertane™ drug through clinical development rapidly, with procedures that permit prompt resolution of the few outstanding issues, so we could commence the trials by the end of this year. This positive guidance will allow us to formalize our negotiations with potential partners."
"This productive meeting with the FDA was expected by the company," continued Mr. Macaluso, "because Zertane™ already successfully completed two phase II and two phase III trials in Europe that met all end points including efficacy and safety. A webcast to inform our shareholders about the status of Zertane™ collaborations as well as more details of the regulatory path in the US and an update on Optina™ clinical results and regulatory strategy for the treatment of DME will be held soon (date and time TBA)."
Zertane™ is a repurposed oral drug to treat premature ejaculation, a condition that has a major impact on the quality of life for men and their sexual partners. The active ingredient in Zertane™ has multiple mechanisms of actions that can delay ejaculation. This drug also has an excellent safety record established during 30 years of human use for other medical indications. These unique pharmaceutical qualities, exceptional human safety record, and a distinctive non-standard dosage and formulation (ODT-Orally Dissolving Tablets) not available in generic form, differentiate Zertane™ from other treatments for premature ejaculation. Zertane™ is taken as needed (on-demand) before sexual activity, and is not required to be taken on a daily basis to be effective.
Ampio Pharmaceuticals, Inc. develops innovative proprietary drugs for inflammation, eye disease, kidney disease, CNS disease, metabolic disease and male sexual dysfunction. The product pipeline includes new uses for previously approved drugs and new molecular entities ("NMEs"). By concentrating on development of new uses for previously approved drugs, approval timelines, costs and risk of clinical failure are reduced because these drugs have strong potential to be safe and effective while their shorter development times can significantly increase near term value. A key strategy includes actively exploring partnership, licensing and other collaboration opportunities to maximize Ampio's product development programs. For more information about Ampio, please visit our website, www.ampiopharma.com.
Ampio's statements in this press release that are not historical fact and that relate to future plans or events are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include risks associated with clinical trials, expected results, regulatory approvals, successful commercialization and marketing of Zertane™ and the combination drug in Korea, and changes in business conditions and similar events. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including Ampio's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
Contact: Rick Giles, Investor Relations Ampio Pharmaceuticals, Inc. 720-437-6500
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Premature ejaculation is a distressing male sexual dysfunction that is more common than erectile dysfunction (ED) and has a major impact on the quality of life for men and their sexual partners.
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