|[January 17, 2014]
Mallinckrodt Pharmaceuticals New Drug Application Approved by the FDA
ST. LOUIS --(Business Wire)--
(NYSE: MNK) today announced that the U.S. Food and Drug Administration
(FDA) has approved the New Drug Application (NDA) for PENNSAID®
(diclofenac sodium topical solution) 2% w/w. PENNSAID 2% is a topical
non-steroidal anti-inflammatory drug (NSAID) approved for use in the
treatment of the pain of osteoarthritis of the knee(s).
PENNSAID 2% is supplied in an easy to use metered dose pump bottle and
is applied twice each day. PENNSAID 2% delivers an accurate amount (20
mg of diclofenac per pump actuation) and can be applied directly to the
"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 approved the
application and believe this product will be an important addition to
the Mallinckrodt Pharmaceuticals product line."
U.S. sales and marketing rights for PENNSAID 2% are licensed to
Mallinckrodt by Nuvo Research Inc.
PENNSAID® (diclofenac sodium topical
solution) 2% w/w
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 treatmnt. 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.
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
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
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.
Prescribing Information for additional Important Risk
Information including boxed warning.
PENNSAID is a registered trademark of Nuvo Research Inc.
Mallinckrodt is a global specialty pharmaceutical 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 active
pharmaceutical ingredients, and the Global Medical Imaging segment
includes contrast media and nuclear imaging agents. Mallinckrodt has
approximately 5,500 employees worldwide and commercial presence in
roughly 70 countries. The company's fiscal 2013 revenue totaled $2.2
billion. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Any statements contained in this communication that do not describe
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,
business, competitive and/or regulatory factors affecting our business.
Any forward-looking statements contained herein are based on our
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
is expressed or implied by these statements. The factors that could
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,
customer concentration, cost-containment efforts of customers,
purchasing groups, third-party payors and governmental organizations,
our ability to successfully develop or commercialize new products, our
ability to protect intellectual property rights, competition, our
ability to integrate acquisitions of technology, products and
businesses, product liability losses and other litigation liability, the
reimbursement practices of a small number of large public or private
issuers, complex reporting and payment obligation under healthcare
rebate programs, changes in laws and regulations, conducting business
internationally, foreign exchange rates, material health, safety and
environmental liabilities, litigation and violations, information
technology infrastructure and restructuring activities. These and other
factors are identified and described in more detail in the "Risk
Factors" section of Mallinckrodt's Annual Report on Form 10-K for the
fiscal year ended September 27, 2013. We disclaim any obligation to
update these forward-looking statements other than as required by law.
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