MISSISSAUGA, ON, Aug. 22, 2013 /PRNewswire/ - 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.
About PENNSAID
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
knee osteoarthritis.
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:
Investor Relations
Email: ir@nuvoresearch.com
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
Cardiovascular 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.
Gastrointestinal Risk
- 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.
CONTRAINDICATIONS
- 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 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 conducted
ADVERSE REACTIONS
- 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.
Forward-Looking Statements
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.