- Trial Results Expected Q2 2017
-
MISSISSAUGA, ON, Oct. 17, 2016 /PRNewswire/ - Nuvo
Pharmaceuticals Inc. (TSX: NRI), (Nuvo or the Company), a
commercial healthcare company with a portfolio of commercial
products and pharmaceutical manufacturing capabilities, today
announced it has received approval from the German Federal
Institute for Drugs and Medical Devices and Ethical Review
Committee to conduct a placebo controlled Phase 3 trial of Pennsaid
2% for the treatment of acute ankle sprains (the Trial). The
130 patient Trial will be conducted in Germany commencing this month. Topline
results are expected to be available in Q2 2017. The Trial is
intended to support regulatory applications for marketing approval
of Pennsaid 2% in the E.U., Canada
and Australia.
"We are excited to get this Trial underway as it is part of our
strategy to expand the Pennsaid 2% brand globally," said
John London, Nuvo's President and
CEO. "Although many jurisdictions will base their regulatory
approval of Pennsaid 2% on its current FDA approval, the E.U.,
Canada and Australia require a successful Phase 3 study
to support our applications for approval. We are in ongoing
discussions with a number of potential international licensing
partners that have the commercial capabilities to effectively
market Pennsaid 2% in their respective jurisdictions."
About the Trial
The Trial will be conducted in
Germany and will enroll
approximately 130 patients who have suffered a grade I or grade II
ankle sprain as assessed by the investigator within 12 hours of
injury. Patients will then be randomly assigned on a
double-blind basis to an active arm or a placebo arm and will apply
either Pennsaid 2% or a placebo consisting of a topical vehicle
that includes all of the constituent ingredients of Pennsaid 2%,
except its active ingredient diclofenac sodium, to their injured
ankle twice a day for 8 days. The patients will return to the
investigational site for in-depth evaluation on days 3, 5 and 8 of
treatment. The primary endpoint for the Trial will be
reduction in pain on movement (POM) at day 3. The Trial will
measure a number of secondary endpoints including tenderness, ankle
function, ankle swelling, overall assessment of benefit and
satisfaction and use of rescue medication. The Trial will
cost approximately CDN$1.5 million
spread over the second half of 2016 and the first half of 2017.
About Pennsaid 2%
Pennsaid 2% is topical non-steroidal
anti-inflammatory drug (NSAID) containing 2% diclofenac
sodium. It is approved by the U.S. Food and Drug
Administration (FDA) for treating the pain of osteoarthritis of the
knee(s). Pennsaid 2% is a gel formulation that is supplied in
a metered dose pump bottle. It is the only topical NSAID
approved by the FDA for twice daily dosing. Pennsaid 2% is
protected by multiple U.S. patents that are listed in the FDA's
Approved Drug Products with Therapeutic Equivalence Evaluations
database or Orange Book. Patents protecting Pennsaid 2% have been
issued or are pending in multiple major international territories.
Pennsaid 2% has not yet received regulatory approval outside of the
U.S.
About Nuvo Pharmaceuticals
Inc.
Nuvo (TSX:NRI) is a commercial healthcare company with
a portfolio of commercial products and pharmaceutical manufacturing
capabilities. Nuvo has three commercial products that are
available in a number of countries; Pennsaid 2%, Pennsaid and the
heated lidocaine/tetracaine patch. Pennsaid 2% is sold
in the U.S. by Horizon Pharma plc (NASDAQ:HZNP) and is available
for partnering in certain other territories around the world.
Nuvo manufactures Pennsaid for the global market and Pennsaid 2%
for the U.S. market at its FDA, Health Canada and EU approved
manufacturing facility in Varennes, Québec. For additional
information, please visit www.nuvopharmaceuticals.com.
Forward-Looking Statements
Certain statements in this press release constitute
forward-looking information and/or forward-looking statements
(collectively, "forward-looking statements") within the meaning of
applicable securities laws. Forward-looking statements include, but
are not limited to, the future approval, marketing and sale of
Pennsaid 2% in certain jurisdictions, as well as statements with
respect to management's beliefs, plans, estimates, and intentions,
and similar statements concerning anticipated future events,
results, circumstances, performance or expectations that are not
historical facts. Forward-looking statements generally can be
identified by the use of forward-looking terminology such as "may",
"will", "expect", "intend", "believe", "should" or "plans", or
similar expressions suggesting future outcomes or events. Such
forward-looking statements reflect management's current beliefs and
are based on information currently available to management.
Forward-looking statements involve risks and uncertainties that
could cause actual results to differ materially from those
contemplated by such statements. Factors that could cause such
differences include, but are not limited to, general business and
economic uncertainties and adverse market conditions; as well as
other risk factors included in the Company's Management Information
Circular dated December 31, 2015 and
the Company's Annual Information Form dated February 17, 2016 under the heading "Risks
Factors", and as described from time to time in the reports and
disclosure documents filed by the Company with Canadian securities
regulatory agencies and commissions. These and other factors should
be considered carefully and readers should not place undue reliance
on the Company's forward-looking statements. As a result of the
foregoing and other factors, no assurance can be given as to any
such future results, levels of activity or achievements and neither
the Company nor any other person assumes responsibility for the
accuracy and completeness of these forward-looking statements.
Although the forward-looking information contained in this press
release is based upon what management believes are reasonable
assumptions, there can be no assurance that actual results will be
consistent with these forward-looking statements. All
forward-looking statements in this press release are qualified by
these cautionary statements. The forward-looking statements
contained herein are made as of the date of this press release and,
except as required by applicable law, the Company undertakes no
obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise.
SOURCE Nuvo Pharmaceuticals Inc.