- Pennsaid 2% Already Approved for
Marketing in the United States and
Russia -
MISSISSAUGA, ON, May 15, 2017
/CNW/ - Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX:NRI),
a commercial healthcare company with a portfolio of commercial
products and pharmaceutical manufacturing capabilities, today
reported topline results from its multi-centre, randomized,
placebo-controlled, double-blind, parallel group trial in patients,
with grade I or II ankle sprains (the Trial) and in particular
reported that the Trial had failed to meet its primary
endpoint.
The Trial
The Trial was conducted in Germany and enrolled 134 patients (the full
analysis set or FAS) of which 122 patients followed the protocol
(the per protocol set or PP) who had suffered a grade I or grade II
ankle sprain as assessed by the investigator within 12 hours of
injury. Patients were randomly assigned on a double-blind
basis to an active arm or a control arm and applied either Pennsaid
2% or a control consisting of a topical vehicle that includes all
the constituent ingredients of Pennsaid 2%, except its active
ingredient diclofenac sodium (the Control) to their injured ankle
twice a day for 8 days. The patients returned to the
investigational site for in-depth evaluation on days 3, 5 and 8 of
treatment. The primary endpoint for the Trial was reduction
in pain on movement (POM) at day 3. The Trial also measured a
number of secondary endpoints including ankle function, meaningful
improvement in pain on movement, overall assessment of benefit and
satisfaction, tenderness and ankle swelling. Patients also
filled out a daily diary that recorded their answers to a number of
standardized questions related to the negative impact of the injury
on sleep and daily activities. The Trial commenced in
November 2016 and was fully enrolled
in March 2017.
Primary Endpoint
The primary endpoint for the Trial
was reduction in pain on movement (POM) at day 3 in the FAS group.
On average, patients treated with Pennsaid 2% had a larger
reduction in POM scores over the course of the study. For the
FAS group, the difference vs. Control was not statistically
significant at the primary time point at day 3 (p=0.5074) or the
secondary time point at day 5 (p=0.1642); however, was
statistically significant at the secondary time point at day 8
(p=0.0099). In the PP group, the Pennsaid 2% group did not
show a statistically significant improvement at day 3 (p=0.6996) or
day 5 (p=0.1865), but did show a statistically significant
improvement at day 8 (p=0.0154).
Secondary Endpoints
The Trial also included the
measure of a number of secondary endpoints.
Ankle Function - Pennsaid 2% demonstrated a
statistically significant increase in ankle function compared to
Control in the FAS group at days 3, 5 and 8 with p-values of
0.0383, 0.0072 and 0.0055, respectively.
Meaningful Improvement in POM
- Pennsaid 2% demonstrated a statistically significant
meaningful improvement in POM compared to Control in the FAS group
at day 5 (p=0.0444) but not at day 3 (p=0.4127) or day 8
(p=0.0961).
Overall Assessment of Benefit and Satisfaction -
Patients treated with Pennsaid 2% reported a statistically
significantly higher level of satisfaction with and benefit of
their treatment compared to Control in the FAS group at day 8 with
a p-value of 0.0164 for the treatment benefit and a p-value of
0.0499 for satisfaction; however, did not report a statistically
higher level of satisfaction and benefit of their treatment
compared to Control at days 3 (p=0.2464 and p=0.1389 for benefit
and satisfaction, respectively) or at day 5 (p=0.1974 and p=0.2548
for benefit and satisfaction, respectively)
Tenderness - Pennsaid 2% did not demonstrate a
statistically significant reduction in tenderness compared to
Control in the FAS group at days 3, 5 and 8 with p-values of
0.1776, 0.4870 and 0.9013, respectively
Ankle Swelling - Pennsaid 2% did not demonstrate a
statistically significant decrease in ankle swelling compared to
Control in the FAS group at days 3, 5 and 8 with p-values of
0.1150, 0.7980 and 0.1042, respectively.
Diary Entries – The daily diary records in
the morning (reflecting on the past night) indicated a distinct
trend that pain had less negative impact on sleep quality (number
of times waking up due to pain and worst intensity of pain
experienced during the night) in the patients treated with Pennsaid
2%; similarly, the daily diary records in the evening (reflecting
on the past day) indicated that Patients treated with Pennsaid 2%
tended to experience less disabling pain during their daily
activities than patients treated with Control.
Purpose of the Trial
Pennsaid 2% is currently approved
by the U.S. Food and Drug Administration (FDA) for the treatment of
the pain of osteoarthritis (OA) of the knee(s). It is also
approved by the Russian Ministry of Health for non-prescription
human use in treating back pain, joint pain, muscle pain, and
inflammation and swelling in soft tissue and joints associated with
trauma and rheumatic conditions. The Trial was conducted to support
regulatory applications for marketing approval of Pennsaid 2% for
the treatment of acute pain in the E.U., Canada and Australia which are potential new markets for
Pennsaid 2%. 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.
Next Steps
The Company will be reviewing the Trial
results in more detail and meeting with its scientific advisors and
regulatory consultants to determine what its next steps should be
in relation to regulatory submissions of Pennsaid 2% in
Canada, Australia and the E.U.
The Trial results will not affect the marketing and sale of
Pennsaid 2% in the U.S. where it is approved by the FDA for the
treatment of the pain of OA of the knee(s) or in Russia where it is approved for
non-prescription human use of Pennsaid 2% in treating back pain,
joint pain, muscle pain, and inflammation and swelling in soft
tissue and joints associated with trauma and rheumatic
conditions.
"We are obviously disappointed by the Trial results," commented
John London, CEO of Nuvo. "Although
the Trial did not achieve its primary endpoint of reduction in pain
on movement at day 3, we saw positive indications in the secondary
endpoints, as well as in the patient diaries that Pennsaid 2% is
beneficial in the treatment of patients with ankle sprains.
We will continue to assess the opportunities available to us
to pursue marketing authorizations for Pennsaid 2% in Canada, Australia and the E.U."
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) and by the Russian Ministry of Health
for non-prescription human use in treating back pain, joint pain,
muscle pain, and inflammation and swelling in soft tissue and
joints associated with trauma and rheumatic conditions.
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
and by the Russian Ministry of Health 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. and Russia.
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 E.U. approved
manufacturing facility in Varennes, Québec. For additional
information, please visit www.nuvopharmaceuticals.com.
Forward-Looking Statements
This Press Release
contains "forward-looking statements" within the meaning of
applicable securities laws. Forward-looking statements can be
identified by words such as: "anticipate," "intend," "plan,"
"goal," "seek," "believe," "project," "estimate," "expect,"
"strategy," "future," "likely," "may," "should," "will" and similar
references to future periods.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based only on
the Company's current beliefs, expectations and assumptions
regarding the future of its business, future plans and strategies,
projections, anticipated events and trends, the economy and other
future conditions. Because forward-looking statements relate to the
future, they are subject to inherent uncertainties, risks and
changes in circumstances that are difficult to predict and many of
which are outside of the Company's control. Nuvo's actual results
and financial condition may differ materially from those indicated
in the forward-looking statements. Therefore, readers should not
rely on any of these forward-looking statements. Important factors
that could cause Nuvo's actual results and financial condition to
differ materially from those indicated in the forward-looking
statements include, among others, the risk factors included in
Nuvo's most recent Annual Information Form dated March 1, 2017 under the heading "Risks Factors",
and as described from time to time in the reports and disclosure
documents filed by Nuvo with Canadian securities regulatory
agencies and commissions. These and other factors should be
considered carefully and readers should not place undue reliance on
Nuvo'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 none of Nuvo or any
other person assumes responsibility for the accuracy and
completeness of these forward-looking statements.
Any forward-looking statement made by the Company in this
Press Release is based only on information currently available to
it and speaks only as of the date on which it is made. Except as
required by applicable securities laws, Nuvo undertakes no
obligation to publicly update any forward-looking statement,
whether written or oral, that may be made from time to time,
whether as a result of new information, future developments or
otherwise.
SOURCE Nuvo Pharmaceuticals Inc.