MISSISSAUGA, ON, July 13, 2016 /CNW/ - Nuvo Pharmaceuticals Inc.
(TSX:NRI) (Nuvo or the Company) today announced it will conduct a
new placebo-controlled, multi-centre Phase 3 trial (Trial) in
Germany to study Pennsaid 2% for
the treatment of acute ankle sprains. Topline results of the
Trial are expected to be available in late Q2 or early Q3 2017.
The Trial is subject to approval by German regulatory
authorities and the ethical review committee. Pennsaid 2% is
currently approved by the U.S. Food and Drug Administration (FDA)
for the treatment of the pain of osteoarthritis of the
knee(s). The Trial will be conducted to support regulatory
applications for marketing approval of Pennsaid 2% for the
treatment of acute pain in the E.U., Canada and Australia. The Company believes that
most other jurisdictions will base their marketing approval on
existing data, including the current U.S. FDA approval of Pennsaid
2% and will not require additional clinical efficacy data.
The Trial will cost approximately CDN$1.5
million spread over the second half of 2016 and the first
half of 2017. The Company believes that potential revenue to
be generated by the Trial far exceeds its modest cost.
"The Trial incorporates what we learned from a similar trial
that we conducted in 2015 that produced encouraging results and we
believe that Pennsaid 2% can show positive results in this
setting," said John London, Nuvo's
President and CEO. "In particular, we have changed the
primary endpoint (pain on movement) to the third day after initial
treatment which was a secondary endpoint at which Pennsaid 2%
demonstrated statistical significance in the 2015 trial."
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.
About Pennsaid 2%
Pennsaid 2% is topical non-steroidal
anti-inflammatory drug (NSAID) containing 2% diclofenac
sodium. It is approved by the 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.
Pennsaid 2% has not yet received regulatory approval outside of the
U.S. Patents protecting Pennsaid 2% have been issued or are
pending in multiple major international territories.
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.