- 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
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.
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.
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.
apply PENNSAID to open wounds
shower for at least 30 minutes after applying PENNSAID
apply external heat and/or occlusive dressings to treated
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.
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.
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.
For further information:
Director, Investor Relations & Corporate Communications
Tel: +1 (905) 673-3617