Ampio Receives FDA Acceptance of its Patient Outcome for Premature Ejaculation
(POPE) Questionnaire, Paving the Way for its US Pivotal Trial on Zertane™
GREENWOOD VILLAGE, Colo., March 11, 2013
GREENWOOD VILLAGE, Colo., March 11, 2013 /PRNewswire/ --Ampio
Pharmaceuticals, Inc. (NASDAQ:AMPE), a biopharmaceutical company developing
drugs to treat prevalent inflammatory diseases, such as osteoarthritis
(Ampion™) and diabetic macular edema (Optina™) and sexual dysfunction
(Zertane™) announced FDA acceptance of its POPE questionnaire, a modification
of the Premature Ejaculation Profile (PEP) questionnaire that was used in the
two successful Zertane™ Phase 3 clinical trials completed in Europe.
Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, explained,"This unique
evaluation tool, named Patient Outcome for Premature Ejaculation (POPE), was
tested in a clinical trial to assure the FDA's SEALD division that the verbal
responses of the patients to physician questions following their treatment
would accurately reflect their clinical response to the drug. The successful
completion of this trial and acceptance of the POPE by the FDA allows Ampio
(or a pharmaceutical partner) to file an IND in the USA for a pivotal trial of
Zertane™ with POPE as a co-primary end-point along with Intravaginal
Ejaculatory Latency Time (IELT). This critically important improvement of the
clinical trial protocol has occupied the company for the last seven months and
we are grateful to the FDA for its assistance and guidance during this facet
of the regulatory path."
Michael Macaluso, Ampio's CEO, noted that "Ampio will be the sole owner of the
POPE, the only FDA accepted outcome measure of efficacy of treatment for PE
and a requirement by the FDA for any clinical trial evaluating treatment of PE
together with the other co-primary end-point, Intravaginal Ejaculatory Latency
Time (IELT). The Zertane™ pivotal trial in the USA is estimated to cost less
than $4 million. The drug has already been manufactured and ready for the
trial. The CMC created for Zertane™ is also being submitted to the TGA (the
Australian FDA) as the last piece for registration of Zertane™ in Australia."
Mr. Macaluso further noted, "The Ampio sexual dysfunction portfolio also
includes Zertane-ED™, a combination of Zertane™'s active ingredient with an
erectile dysfunction drug to treat comorbid PE and Erectile Dysfunction (ED).
Men with ED suffer from PE about 30% of the time. Zertane-ED™ is under
development by Ampio and has been formulated so that the peak activities of
its two components (PE and ED) are synchronous. Ampio was awarded multiple
patents on the combinations of Zertane™ with any PDE5 inhibitors.
Additionally, Daewoong Co. Ltd, our South Korean partner, has agreed to
finance and conduct the first clinical trial on Zertane-ED™ in Korea in
compliance with FDA requirements. With everything in place for Zertane™ and a
very low cost pivotal trial, all options are open to us and we can make the
best possible decision for our shareholders."
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a biopharmaceutical company focused on the
rapid development of therapies to treat prevalent inflammatory conditions for
which there are limited treatment options. It aims to provide medicines to
improve the health and quality of life of patients with minimal side effects.
Ampio is developing compounds that decrease inflammation by 1) inhibition of
specific pro-inflammatory compounds by affecting specific pathways at the
protein expression and at the transcription level or 2) activation of a
specific phosphatase or depletion of the available phosphate needed for the
inflammation process and 3) decreasing vascular permeability/leakage, an
upstream event in inflammation. For more information visit:
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Director of Investor Relations
Ampio Pharmaceuticals, Inc.
Direct (720) 437-6530
SOURCE Ampio Pharmaceuticals, Inc.
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