MISSISSAUGA, ON, Feb. 10, 2014 /PRNewswire/ - Nuvo Research Inc.
(TSX: NRI), a specialty pharmaceutical company with a diverse
portfolio of topical and immunology products today announced the
U.S. commercial launch of PENNSAID (diclofenac sodium topical
solution) 2% w/w (PENNSAID 2%) by its U.S. commercial licensee
Mallinckrodt (NYSE:MNK). PENNSAID
2% is the first twice per day topical non-steroidal
anti-inflammatory drug (NSAID) approved for use in the United States for the treatment of the
pain of osteoarthritis of the knee(s). Nuvo receives
royalties on U.S. sales of PENNSAID 2%.
"We believe the commercial launch of PENNSAID 2%
has the potential to generate increased sales from which Nuvo can
receive increased royalties," said Dan
Chicoine, Chairman and co-CEO. "PENNSAID 2% provides a
topical treatment option to the millions of U.S. patients suffering
from the pain of osteoarthritis of the knee while providing a lower
systemic drug exposure than an oral NSAID."
PENNSAID 2% was approved by the U.S. Food and
Drug Administration on January 16,
2014. U.S. sales and marketing rights for PENNSAID 2%
are licensed to Mallinckrodt by Nuvo
Research Inc.
About PENNSAID 2%
PENNSAID 2% is a follow-on product to original PENNSAID (diclofenac
sodium topical solution) 1.5% w/w (PENNSAID 1.5%) 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 1.5%. It is more viscous than original
PENNSAID 1.5%, is supplied in a metered dose pump bottle and has
been approved for twice daily dosing compared to four times a day
for original PENNSAID 1.5%.
About Nuvo Research Inc.
Nuvo (TSX:NRI) is a specialty pharmaceutical company focused on
improving patient's lives by developing and commercializing
innovative products that address unmet medical needs. The
Company has a diverse portfolio of topical and immunology
products.
Nuvo's marketed products include PENNSAID 1.5%
(a topical treatment for the signs and symptoms of osteoarthritis
of the knee), PENNSAID 2% (a topical treatment for the pain of
osteoarthritis of the knee), Pliaglis (a topical local anesthetic)
and the heated lidocaine/tetracaine patch (HLT Patch). For
additional Company information visit www.nuvoresearch.com.
PENNSAID® (diclofenac sodium topical solution) 2%
w/w
IMPORTANT RISK INFORMATION
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK
Cardiovascular Risk
- Nonsteroidal 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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CONTRAINDICATIONS
- 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
WARNINGS AND PRECAUTIONS
- 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.
- 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.
- Wash and dry hands before and after use. Avoid contact of
PENNSAID with the eyes and mucous membranes
- PENNSAID was not evaluated under the conditions of heat
application, occlusive dressings overlay, or exercise; therefore,
concurrent use of PENNSAID under these conditions is not
recommended.
- Do not:
-
- apply PENNSAID to open wounds.
- shower for at least 30 minutes after applying PENNSAID.
- wear clothing over the PENNSAID treated knee until the treated
knee is dry
- Protect treated knee(s) from natural or artificial sunlight.
Topicals, such as sunscreen and bug repellent, may be applied after
PENNSAID treated knee(s) are completely dry.
- Concurrent use with oral NSAIDs should be avoided unless
benefit outweighs risk and periodic laboratory evaluations are
conducted
ADVERSE REACTIONS
- The most common adverse events in a phase 2 clinical trial of
PENNSAID 2% were application site reactions, such as dryness (22%),
exfoliation (7%), erythema (4%), pruritus (2%), pain (2%),
induration (2%), rash (2%), and scabbing (1%). Other adverse
reactions occurring in >1% of patients receiving PENNSAID 2%
included urinary tract infection (3%), contusion (2%), sinus
congestion (2%), and nausea (2%).
- The most common treatment-related adverse events in patients
receiving PENNSAID 1.5% 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%).
USE IN SPECIFIC POPULATIONS
- PENNSAID should not be used in pregnant or lactating women and
is not approved for use in pediatric patients.
Click here for Full Prescribing Information for
additional Important Risk Information including boxed
warning.
PENNSAID is a registered trademark of Nuvo Research Inc.
Forward-Looking Statements
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.