FDA requests U.S. licensee cease distribution of PENNSAID sample bottles
due to concerns of incorrect administration by patients
No disruption to commercial availability
MISSISSAUGA, ON, Nov. 14, 2011 /CNW/ -Nuvo Research Inc. (TSX: NRI), a
specialty pharmaceutical company dedicated to building a portfolio of
products for the topical treatment of pain and the development of its
immune modulating drug candidate WF10, today announced that its U.S.
marketing partner, Mallinckrodt Inc., a Covidien company, has advised
Nuvo that, at the request of the U.S. Food and Drug Administration
(FDA), Mallinckrodt has ceased distribution of 15 mL sample bottles of
Pennsaid to U.S. healthcare professionals. Mallinckrodt is the
subsidiary of Covidien that holds the U.S. marketing rights to PENNSAID
and that deals with the FDA in all matters respecting PENNSAID.
Mallinckrodt has advised Nuvo that it had previously submitted to the
FDA five reports of patients who had used an incorrect route of drug
administration with PENNSAID topical solution either orally (into the
mouth) or optically (into the eye) using the 15 mL sample bottle.
PENNSAID is a topical solution approved only for direct application to
the skin overlying the knee for the treatment of the signs and symptoms
of osteoarthritis (OA) of the knee. There were no serious adverse
outcomes in these five patients, and in all reported confirmed cases,
the adverse events that resulted from the improper route of
administration were resolved.
Mallinckrodt has advised Nuvo that the FDA request does not extend to
the 150 mL commercial size bottles of PENNSAID marketed by
Mallinckrodt. Nuvo does not expect any disruption in PENNSAID's
commercial supply and Mallinckrodt remains free to market and
distribute the product actively in the United States. Mallinckrodt has
advised Nuvo that it intends to communicate further with the FDA in an
effort to resolve this matter in a timely fashion. Nuvo currently
receives manufacturing revenues from Mallinckrodt for production of the
sample bottles and expects that manufacturing of the sample bottles
will be suspended for an indeterminate period of time. Nuvo believes
that if Mallinckrodt is unable to resolve this matter in a timely
fashion, its inability to provide samples to U.S. healthcare
professionals could have a negative impact on PENNSAID sales in the
U.S. and the royalties Nuvo receives on these sales, unless
Mallinckrodt successfully implements mitigating strategies.
PENNSAID (diclofenac sodium topical solution, 1.5% w/w) is an FDA
approved nonsteroidal anti-inflammatory drug (NSAID) indicated for the
treatment of the signs and symptoms of OA of the knee(s). PENNSAID is
currently recommended for topical application of 40 drops 4 times per
day to the front, back and sides of the knee. Additional information
for U.S. patients and physicians is available at www.pennsaid.com.
About Osteoarthritis of the Knee
OA is one of the most common forms of degenerative joint disease. In the
U.S., approximately 27 million adults aged 25 and older suffer from
clinical OA. In adults, arthritis is one of the leading causes of
disability and is among the most common conditions resulting in work
limitations. OA of the knee is the most frequent form of lower
extremity arthritis and contributes to 418,000 knee replacement
About Nuvo Research Inc.
Nuvo Research is a publicly traded, Canadian specialty pharmaceutical
company, headquartered in Mississauga, Ontario. The Company is
building a portfolio of products for the treatment of pain through
internal research and development and by in-licensing and acquisition.
The Company's Pain Group, located in West Chester, Pennsylvania, is
focused on the development and commercialization of topically delivered
pain products. The Company's product portfolio includes PENNSAID,
Pliaglis and Synera. PENNSAID, a topical nonsteroidal
anti-inflammatory drug (NSAID), is used to treat the signs and symptoms
of osteoarthritis of the knee(s). PENNSAID is sold in the United
States by Mallinckrodt Inc., a Covidien company, in Canada by Paladin
Labs Inc. and in several European countries. Pliaglis is a topical
local anesthetic cream, which is U.S. Food and Drug Administration
(FDA) approved to provide topical local analgesia for superficial
dermatological procedures. The Company has licensed worldwide
marketing rights to Pliaglis to Galderma Pharma S.A., a global
specialty pharmaceutical company focused on dermatology. Synera is a
topical patch that combines lidocaine, tetracaine and heat, approved in
the United States to provide local dermal analgesia for superficial
venous access and superficial dermatological procedures and in Europe,
for surface anaesthesia of normal intact skin. Nuvo currently markets
Synera in the United States and its licensing partner, EuroCept
International B.V., has initiated a pan-European launch of Synera
(under the name Rapydan) in several European countries. Through its
subsidiary, Nuvo Research GmbH, based in Leipzig, Germany, the Company
is also developing the compound WF10, for the treatment of immune
related diseases. For more information, please visit www.nuvoresearch.com.
IMPORTANT RISK INFORMATION ABOUT PENNSAID
Non-steroidal 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.
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
Should not be used in pregnant or lactating women and is not approved
for use in pediatric patients.
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.
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
Do not apply to open wounds. Protect treated knee(s) from natural or
artificial sunlight. Topicals such as sunscreen and bug repellant 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
See Full Prescribing Information for additional Important Risk Information.
This document contains forward-looking statements. Some forward-looking
statements may be identified by words like "expects", "anticipates",
"plans", "intends", "indicates" or similar expressions. These
forward-looking statements, by their nature, necessarily involve risks
and uncertainties that could cause actual results to differ materially
from those contemplated by the forward-looking statements. Nuvo
considers the assumptions on which these forward-looking statements are
based to be reasonable at the time they were prepared, but caution that
these assumptions regarding future events, many of which are beyond the
control of the Company, may ultimately prove to be incorrect. Factors
and risks, which could cause actual results to differ materially from
current expectations, are discussed in the annual report, as well as in
Nuvo's Annual Information Form for the year ended December 31, 2010.
Nuvo disclaims any intention or obligation to update or revise any
forward-looking statements, whether as a result of new information or
future events, except as required by law. For additional information on
risks and uncertainties relating to these forward looking statements,
investors should consult the Company's ongoing quarterly filings,
annual report and Annual Information Form and other filings found on
SEDAR at www.sedar.com.
SOURCE Nuvo Research Inc.
For further information:
Westwicke Partners, LLC
Tel: (443) 213-0506