Ampio Announces Positive Results From 12-Week Open Label Extension Study of Zertane in Patients With Premature Ejaculation
09/26/2011 | Press Release
GREENWOOD VILLAGE, Colo., Sept. 26, 2011 -- Ampio Pharmaceuticals, Inc. (NASDAQ:AMPE - News) ("Ampio" or the "Company"), a company that discovers and develops new uses for previously approved drugs and new molecular entities ("NMEs"), today announced positive results from a 12-week open label extension study that was performed at the conclusion of the Phase III trials for Zertane™ in patients with premature ejaculation. No treatment-related serious adverse events and very few adverse events were recorded during the open-label extension period, when all subjects received active treatment, even though the mean extent of exposure (approximately 0.26 to 0.31 tablets per day) appeared to increase modestly compared to the double-blind treatment period (approximately 0.24 to 0.26 tablets per day). The average use by patients during this 12 week period remained less than 3 pills per week. Six subjects experienced an adverse event (5.9%) with only one treatment-related adverse event (anxiety/erectile dysfunction), demonstrating that even the higher dose of Zertane™ proves to be safe with a longer follow-up. There were no reports of dependency or tolerability issues.
"These findings of safety during an extended period of time beyond our Phase III clinical trial in men with premature ejaculation help diminish any potential concerns about safety or dependency with the use of the active ingredient of Zertane™," said Don Wingerter, Ampio CEO.
About the Study
The two Phase III trials for Zertane™ were conducted in 62 sites and 11 countries in Europe (results recently published in European Urology). In the open label extension trial, all subjects participating in this study (n=101) received the higher dose of Zertane™ (89 mg), and were evaluated at 3-week intervals for a total of four visits. Safety data collected during the open label extension period included laboratory tests, vital signs, electrocardiograms, adverse events, serious adverse events and treatment emergent adverse events.
Zertane is a new use for tramadol hydrocloride, a drug approved for marketing as a noncontrolled analgesic in 1995. Zertane, in two Phase III clinical trials, has proven to be an effective oral medication to treat premature ejaculation, or PE, in men. Premature ejaculation is the most common form of male sexual dysfunction with an estimated 23% of males suffering from premature ejaculation (four times the number with erectile dysfunction). PE has a major impact on the quality of life for many men and their partners. Behavioral therapy is the current standard of care for treatment of PE.
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 Pharmaceuticals, Inc. develops innovative proprietary drugs for metabolic disease, eye disease, kidney disease, inflammation, CNS disease, and male sexual dysfunction. The product pipeline includes new uses for previously approved drugs and new molecular entities ("NMEs").
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.
Ampio Pharmaceuticals, Inc.
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