Navigation Links
Ampio Announces Positive Results From 12-Week Open Label Extension Study of Zertane™ in Patients With Premature Ejaculation.
Date:9/26/2011

GREENWOOD VILLAGE, Colo., Sept. 26, 2011 /PRNewswire/ -- 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.

About Zertane

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.

About Ampio

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").

Forward-Looking Statements

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:
Investor Relations
Ampio Pharmaceuticals, Inc.
720-437-6500


'/>"/>
SOURCE Ampio Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Champions Oncology Reports Fiscal 2012 First Quarter Financial Results
2. Ampio Pharmaceuticals Executes License and Development Agreement with Daewoong Co. Ltd. to Commercialize Zertane™ in South Korea
3. Ampio Pharmaceuticals Announces Treatment of First Patient in Phase 1b Ampion-In -Knee (AIK) Trial for Osteoarthritis in Australia
4. Ampio Pharmaceuticals, Inc. Releases Results From Phase III Clinical Trial of Zertane™ for the Treatment of Premature Ejaculation (PE), the Most Prevalent Form of Male Sexual Dysfunction
5. Ampio Pharmaceuticals Set to Join Russell 3000 Index
6. Ampio Pharmaceuticals, Inc. Appoints New Independent Director
7. Ampio Pharmaceuticals, Inc. to Begin Trading on the NASDAQ Capital Market
8. Ampio Pharmaceuticals, Inc. Receives Approval to List on the NASDAQ Capital Market
9. Five Californians Selected as Breakaway from Cancer® Champions to be Honored During Amgen Tour of California
10. Champions Biotechnology Exercises Option to License Proprietary Compound Based on Successful Tumorgraft™ Test Results
11. Ampio Pharmaceuticals, Inc. Announces Appointment of New Chief Financial Officer to be Effective April 4, 2011
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/20/2017)... Research and Markets has announced the addition of the ... Market and Increasing Usage of Complex Biologics during the Forecast Period" ... ... 20 Billion in 2015 to around USD 26 Billion by 2020. ... by Rapidly Expanding Injectables Market and Increasing Usage of Complex Biologics ...
(Date:4/20/2017)... April 20, 2017  AbbVie (NYSE: ABBV), a ... (n=145/146) of chronic hepatitis C virus (HCV) infected ... 6 and compensated cirrhosis (Child-Pugh A) achieved sustained ... ) with its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir ... seen following 12 weeks of G/P treatment without ...
(Date:4/20/2017)... , April 20, 2017 NeuroVive ... ("NeuroVive") today announced positive preclinical results demonstrating ... compound for non-alcoholic steatohepatitis (NASH), in an ... NV556 has previously shown similar ... model. Today, NeuroVive,s scientists present novel data ...
Breaking Medicine Technology:
(Date:4/25/2017)... ... 2017 , ... ProRehab Physical Therapy (PRPT) is ... therapy provider for Derby City CrossFit, effective immediately. , In addition to treating ... effectively as possible, ProRehab’s sports physical therapists will work with athletes to maximize ...
(Date:4/25/2017)... ... 2017 , ... A recent report from the Wisconsin Institute ... 2015-16 school year across Wisconsin’s public schools, charter schools, and private schools participating ... student test score performance, the report’s limited analyses fail to provide answers as ...
(Date:4/25/2017)... , ... April 25, 2017 , ... ... they rely on contracted partners to help with process innovation in drug formulation ... drug formulation experience along with state-of-the-art analytical equipment in support of their development ...
(Date:4/25/2017)... ... 25, 2017 , ... Saad B. Chaudhary, MD is committed to providing the highest quality of ... I focus on preventative care with all my patients to alleviate possible future issues. I ... free to contact my office and my trained staff will assist you in any way ...
(Date:4/25/2017)... ... 25, 2017 , ... Vetoquinol USA® , a world-class ... part of the EQUISTRO line, at this week’s Rolex Kentucky Three-Day Event in ... immunologic level. , The scientifically-developed Flexadin UCII supports the body’s normal repair of ...
Breaking Medicine News(10 mins):