MISSISSAUGA, ON, July 23, 2013 /PRNewswire/ - Nuvo Research Inc.
(Nuvo) (TSX: NRI), a specialty pharmaceutical company dedicated to
building a portfolio of products for the topical treatment of pain
announced today that its U.S. licensing partner, Mallinckrodt, (NYSE:MNK) has successfully completed
a pharmacokinetic (PK) study comparing diclofenac sodium topical
solution, 2% w/w (PENNSAID 2%) to original PENNSAID. On
March 4, 2013, Mallinckrodt received a Complete Response Letter
from the U.S. Food and Drug Administration (FDA) following the
review of Mallinckrodt's New Drug
Application for PENNSAID 2%. In the letter, the FDA required
that Mallinckrodt successfully complete
the PK study.
Mallinckrodt has
indicated to Nuvo that they expect to send the PENNSAID 2%
resubmission to the FDA within the next 60 days. Mallinckrodt anticipates the FDA will provide a
formal response to the filing within 6 months of the
submission.
About PENNSAID
PENNSAID is a non-steroidal anti-inflammatory
drug (NSAID) used for treating the signs and symptoms of
osteoarthritis of the knee(s).
PENNSAID is the only FDA-approved topical NSAID
for the treatment of knee osteoarthritis which demonstrated
statistically significant differences in all three primary efficacy
endpoints: pain and physical function (WOMAC®), patient
overall health assessment (POHA), and patient global assessment of
knee osteoarthritis.
PENNSAID is a registered trademark of Nuvo
Research Inc.
WOMAC is a registered trademark of Nicholas Bellamy.
WOMAC® is a proprietary health status
questionnaire. For further information visit the WOMAC®
website at www.WOMAC.com.
About PENNSAID 2%
PENNSAID 2% is a follow-on product to original
PENNSAID which is currently marketed in the U.S. by Mallinckrodt under license from Nuvo.
PENNSAID 2% is a topical non-steroidal anti-inflammatory drug
(NSAID) containing 2% diclofenac sodium compared to 1.5% for
original PENNSAID. It is more viscous than original PENNSAID,
is supplied in a metered dose pump bottle and was studied in
clinical trials using twice daily dosing compared to four times a
day for original PENNSAID.
About Nuvo Research Inc.
Nuvo is a publicly traded, Canadian specialty
pharmaceutical company, headquartered in Mississauga, Ontario. The Company is
building a portfolio of products for the treatment of pain through
internal research and development. The Company's product
portfolio includes Pennsaid®, Pliaglis and a heated
lidocaine/tetracaine patch (HLT patch). PENNSAID, a topical
non-steroidal anti-inflammatory drug (NSAID), is used to treat the
signs and symptoms of osteoarthritis of the knee(s). PENNSAID
is sold in the U.S. by Mallinckrodt, in
Canada by Paladin Labs Inc. and in
several European countries. Pliaglis is a topical local
anesthetic cream which provides topical local analgesia for
superficial dermatological procedures. The Company has
licensed worldwide marketing rights to Pliaglis to Galderma Pharma
S.A., a global pharmaceutical company specialized in
dermatology. Galderma launched the marketing and sale of
Pliaglis in the U.S. in March of 2013 and in the E.U. in April of
2013. The HLT patch is a topical patch that combines
lidocaine, tetracaine and heat and is approved in the U.S. to
provide local dermal analgesia for superficial venous access and
superficial dermatological procedures and in Europe, for surface anaesthesia of normal
intact skin. Nuvo's licensing partner, Galen US Incorporated
markets the HLT patch (under the name Synera) in the U.S. In
Europe, Nuvo's licensing partner, Eurocept International B.V., has
initiated a pan-European launch of the HLT patch (under the name
Rapydan). The Company is also developing WF10, for the
treatment of immune related diseases.
INDICATION
PENNSAID® is a non-steroidal
anti-inflammatory drug (NSAID) indicated for the treatment of signs
and symptoms of osteoarthritis of the knee(s).
IMPORTANT RISK INFORMATION ABOUT
PENNSAID®
Cardiovascular Risk
- Non-steroidal anti-inflammatory drugs (NSAIDs) may cause an
increased risk of serious cardiovascular thrombotic events,
myocardial infarction, and stroke, which can be fatal. This risk
may increase with duration of use. Patients with cardiovascular
disease or risk factors for cardiovascular disease may be at
greater risk.
- PENNSAID is contraindicated in the perioperative setting of
coronary artery bypass graft (CABG) surgery.
Gastrointestinal Risk
- NSAIDs cause an increased risk of serious gastrointestinal
adverse events including bleeding, ulceration, and perforation of
the stomach or intestines, which can be fatal. These events can
occur at any time during use and without warning symptoms. Elderly
patients are at greater risk for serious gastrointestinal
events.
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PENNSAID is also contraindicated in
patients:
- with a known hypersensitivity to diclofenac sodium or any other
component of PENNSAID
- who have experienced asthma, urticaria, or allergic-type
reactions after taking aspirin or other NSAIDs. Severe, rarely
fatal anaphylactic-like reactions to NSAIDs have been reported in
such patients.
Elevation of one or more liver tests may occur
during therapy with NSAIDs. PENNSAID should be discontinued
immediately if abnormal liver tests persist or worsen.
Use with caution in patients with fluid
retention or heart failure. Hypertension can occur with NSAID
treatment. Monitor blood pressure closely with PENNSAID
treatment.
Long-term administration of NSAIDs can result in
renal papillary necrosis and other renal injury. Use PENNSAID with
caution in patients at greatest risk of this reaction, including
the elderly, those with impaired renal function, heart failure,
liver dysfunction, and those taking diuretics and
ACE-inhibitors.
Should not be used in pregnant or lactating
women and is not approved for use in pediatric patients.
Anaphylactoid reactions may occur in patients
without prior exposure to PENNSAID. NSAIDs can cause serious skin
adverse events such as exfoliative dermatitis, Stevens-Johnson
Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be
fatal.
The most common treatment-related adverse events
in patients receiving PENNSAID were application site skin reactions
including dry skin (32%), contact dermatitis characterized by skin
erythema and induration (9%), contact dermatitis with vesicles (2%)
and pruritus (4%). In a long term safety study, contact dermatitis
occurred in 13% and contact dermatitis with vesicles in 10% of
patients, generally within the first 6 months of exposure, leading
to a withdrawal rate for an application site event of 14%.
Other common adverse events greater than placebo include: dyspepsia
(9%), abdominal pain (6%), flatulence (4%), diarrhea (4%) and
nausea (4%).
Do not apply to open wounds. Protect treated
knee(s) from natural or artificial sunlight. Topicals such as
sunscreen and bug repellant may be applied after PENNSAID treated
knee(s) are completely dry. Avoid contact of PENNSAID with eyes and
mucous membranes. Wash and dry hands after use.
Concurrent use with oral NSAIDs should be
avoided unless benefit outweighs risk and periodic laboratory
evaluations are conducted.
See Full Prescribing Information for additional
Important Risk Information.
Forward-Looking Statements for Nuvo Research
Inc.
Certain statements in this news release
constitute forward-looking statements within the meaning of
applicable securities laws. Forward-looking statements
include, but are not limited to, statements concerning the
Company's future objectives, strategies to achieve those
objectives, 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 "outlook", "objective",
"may", "will", "expect", "intend", "estimate", "anticipate",
"believe", "should", "plans" or "continue", 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 the need for additional financing, the
current economic environment, dependence on sales and marketing
partnerships, competitive developments, as well as other risk
factors included in the Company's annual information form dated
March 27, 2013 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. This list is
not exhaustive of the factors that may impact the Company's
forward-looking statements. 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. The factors underlying current expectations are
dynamic and subject to change. Although the forward-looking
information contained in this news 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. Certain statements included in
this news release may be considered "financial outlook" for
purposes of applicable securities laws, and such financial outlook
may not be appropriate for purposes other than this news
release. All forward-looking statements in this news release
are qualified by these cautionary statements. The
forward-looking statements contained herein are made as of the date
of this news 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 Research Inc.