Mallinckrodt Pharmaceuticals’ New Drug Application Accepted for Review by
Mallinckrodt’s MNK-395 – diclofenac sodium topical solution 2% w/w accepted
for filing by U.S. Food and Drug Administration
ST. LOUIS -- August 22, 2013
Mallinckrodt (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
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^® (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 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
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
*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 conducted.
*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
USE IN SPECIFIC POPULATIONS
*PENNSAID should not be used in pregnant or lactating women and is not
approved for use in pediatric patients.
See Full Prescribing Information for additional Important Risk Information.
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,
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expectations include, but are not limited to, our ability to receive
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Lynn Phillips, 314-654-3263
Manager, Media Relations
Meredith Fischer, 314-654-6595
Senior Vice President, Communications
John Moten, 314-654-6650
Vice President, Investor Relations
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