- Mallinckrodt to Launch PENNSAID
2% in the U.S. in Q1 2014 -
MISSISSAUGA, ON, Jan. 17, 2014 /CNW/ - Nuvo Research Inc.
(TSX:NRI), a specialty pharmaceutical company with a diverse
portfolio of products in the areas of topical pain and immunology
today announced that the U.S. Food and Drug Administration (FDA)
has approved Mallinckrodt's New Drug
Application for PENNSAID® (diclofenac sodium topical
solution) 2% w/w (PENNSAID 2%).
PENNSAID 2% is a follow-on product to original
PENNSAID (diclofenac sodium topical solution) 1.5% w/w (PENNSAID
1.5%) which has been marketed by Mallinckrodt in the U.S. since 2010. PENNSAID 2%
will be the first twice per day dosed topical NSAID available in
the U.S. for the treatment of the pain of osteoarthritis of the
knee. Nuvo has licensed the U.S. sales and marketing rights for
both PENNSAID 1.5% and PENNSAID 2% to Mallinckrodt.
"The approval of PENNSAID 2% is a significant
milestone for Nuvo," said Dan
Chicoine, Chairman and Co-Chief Executive Officer of Nuvo
Research. "We are pleased that the FDA has approved this product
for patients suffering from the pain of osteoarthritis of the
knee."
PENNSAID (diclofenac sodium topical solution) 2% w/w
INDICATIONS AND USAGE
PENNSAID (diclofenac sodium topical solution) 2% w/w is a
nonsteroidal anti-inflammatory drug (NSAID) indicated for the
treatment of pain of osteoarthritis of the knee(s).
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 membrane.
- Do not:
apply
PENNSAID to open wounds
shower
for at least 30 minutes after applying PENNSAID
apply
external heat and/or occlusive dressings to treated knees
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 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
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.
About PENNSAID 1.5%
PENNSAID 1.5% is a non-steroidal
anti-inflammatory drug (NSAID) used for treating the signs and
symptoms of osteoarthritis of the knee(s).
PENNSAID 1.5% 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 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 products in the areas of topical
pain and immunology.
Nuvo's marketed products include PENNSAID (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.
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Company's future objectives, strategies to achieve those
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Forward-looking statements generally can be identified by the use
of forward-looking terminology such as "outlook", "objective",
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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
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SOURCE Nuvo Research Inc.