Mallinckrodt Pharmaceuticals’ New Drug Application Accepted for Review by FDA
Mallinckrodt’s MNK-395 – diclofenac sodium topical solution 2% w/w
accepted for filing by U.S. Food and Drug Administration
ST. LOUIS--(BUSINESS WIRE)--Aug. 22, 2013--
(NYSE: MNK) today announced that the U.S. Food and Drug Administration
(FDA) has accepted for filing the New Drug Application (NDA) for
MNK-395. MNK-395 is referred to in the application as PENNSAID®
(diclofenac sodium topical solution) 2% w/w, studied in the treatment of
the pain of osteoarthritis of the knee.
The NDA was resubmitted by Mallinckrodt on August 7, 2013, in answer to
a Complete Response Letter from the FDA that included the request for an
additional pharmacokinetic study.
“We have a diverse portfolio focused on pain management, and are
committed to providing options for patients who suffer from
osteoarthritis of the knee,” said Mark Trudeau, Chief Executive Officer
and President, Mallinckrodt. “We are pleased that the FDA accepted the
application for filing. If approved, this product will be an important
addition to the Mallinckrodt Pharmaceuticals product line.”
Mallinckrodt continues to market PENNSAID (diclofenac sodium topical
solution) 1.5% w/w, a nonsteroidal anti-inflammatory drug (NSAID) used
for the treatment of the signs and symptoms of osteoarthritis of the
knee. Under the terms of a U.S. Licensing and Development Agreement with
Nuvo Research signed in June 2009, Mallinckrodt is responsible for
managing development activities for PENNSAID 2%.
PENNSAID® (diclofenac sodium topical
solution) 1.5% w/w
INDICATIONS AND USAGE
PENNSAID® (diclofenac sodium topical solution) 1.5% w/w is a
nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment
of signs and symptoms 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
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
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.
Do not apply to open wounds. 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. 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
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%).
USE IN SPECIFIC POPULATIONS
PENNSAID should not be used in pregnant or lactating women and is not
approved for use in pediatric patients.
Prescribing Information for additional Important Risk
PENNSAID is a registered trademark of Nuvo Research Inc.
Mallinckrodt is a leading global specialty pharmaceuticals business that
develops, manufactures, markets, and distributes specialty
pharmaceutical products and medical imaging agents. The Company’s
Specialty Pharmaceuticals segment includes branded and generic drugs,
and the Global Medical Imaging segment includes contrast media and
nuclear imaging agents. Mallinckrodt has approximately 5,500 employees
worldwide with a direct sales presence in roughly 50 countries and
distribution in approximately 40 other countries. The Company’s 2012
revenue totaled $2.1 billion. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
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historical facts may constitute forward-looking statements as that term
is defined in the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements include, but are not limited to, statements
about future financial condition and operating results, economic,
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management's current beliefs and expectations, but are subject to a
number of risks, uncertainties and changes in circumstances, which may
cause actual results or Company actions to differ materially from what
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cause actual future results to differ materially from current
expectations include, but are not limited to, our ability to receive
procurement and production quotas granted by the U.S. Drug Enforcement
Administration, our ability to obtain and/or timely transport
molybdenum-99 to our technetium-99m generator production facilities,
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our ability to successfully develop or commercialize new products, our
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these forward-looking statements other than as required by law.
Lynn Phillips, 314-654-3263
Senior Vice President, Communications
Vice President, Investor Relations