MISSISSAUGA, ON, Aug. 22, 2013 /CNW/ - Nuvo Research Inc. (Nuvo) (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. licensee for PENNSAID(®
)(diclofenac sodium topical solution) 1.5% w/w and PENNSAID 2% (diclofenac
sodium topical solution) 2% w/w, Mallinckrodt (NYSE:MNK) has advised that the
U.S. Food and Drug Administration (FDA) has accepted for filing and review the
New Drug Application (NDA) for PENNSAID 2% submitted by Mallinckrodt on August
7, 2013. The FDA has indicated to Mallinckrodt that it expects to respond to
the NDA by February 7, 2014.
On March 4, 2013, Mallinckrodt received a Complete Response Letter (CRL) from
the FDA following the review of Mallinckrodt's New Drug Application for
PENNSAID 2%. In the CRL, the FDA required that Mallinckrodt complete a
pharmacokinetic (PK) study comparing PENNSAID 2% to original PENNSAID.
Mallinckrodt completed the PK study and on August 7, 2013 submitted the
clinical study report to the FDA.
PENNSAID is a non-steroidal anti-inflammatory drug (NSAID) used for treating
the signs and symptoms of osteoarthritis of the knee(s).
PENNSAID 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
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 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. It is more viscous
than original PENNSAID, is supplied in a metered dose pump bottle and was
studied in clinical trials using twice daily dosing compared to four times a
day for original PENNSAID.
About Nuvo Research Inc.
Nuvo 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. The Company's product portfolio includes Pennsaid(®), Pliaglis
and a heated lidocaine/tetracaine patch (HLT patch). Pennsaid, a topical
non-steroidal anti-inflammatory drug (NSAID), is used to treat the signs and
symptoms of osteoarthritis of the knee(s). Pennsaid is sold in the U.S. by
Mallinckrodt Inc. in Canada by Paladin Labs Inc. and in several European
countries. Pliaglis is a topical local anesthetic cream which provides
topical local analgesia for superficial dermatological procedures. The
Company has licensed worldwide marketing rights to Pliaglis to Galderma Pharma
S.A., a global pharmaceutical company specialized in dermatology. Galderma
launched the marketing and sale of Pliaglis in the U.S. in March of 2013 and
in the E.U. in April of 2013. The HLT patch is a topical patch that combines
lidocaine, tetracaine and heat and is approved in the U.S. to provide local
dermal analgesia for superficial venous access and superficial dermatological
procedures and in Europe, for surface anaesthesia of normal intact skin.
Nuvo's licensing partner, Galen US Incorporated markets the HLT patch (under
the name Synera) in the U.S. In Europe, Nuvo's licensing partner, Eurocept
International B.V., has initiated a pan-European launch of the HLT patch
(under the name Rapydan). The Company is also developing WF10, for the
treatment of immune related diseases.
Further information on Nuvo Research is available on the company's website
www.nuvoresearch.com or by contacting:
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
-- 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 anaphylacticlike 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
-- 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
-- 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 (4%).
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.
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.
Nuvo Research Inc. Email:firstname.lastname@example.org
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