Nuvo Research® announces that FDA has accepted Pennsaid® 2% new drug application for review

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 
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 
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 or by contacting: 
Investor Relations
PENNSAID(®) (diclofenac sodium topical solution) 1.5% w/w 
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). 
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.

    --  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

    --  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
    --  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%).


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. 
Nuvo Research Inc. 
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