Nuvo Research Announces FDA Approval of PENNSAID® 2%

- Mallinckrodt to Launch PENNSAID 2% in the U.S. in Q1 2014 - 
MISSISSAUGA, ON, Jan. 17, 2014 /CNW/ - Nuvo Research Inc. (TSX:NRI), a 
specialty pharmaceutical company with a diverse portfolio of products in the 
areas of topical pain and immunology today announced that the U.S. Food and 
Drug Administration (FDA) has approved Mallinckrodt's New Drug Application for 
PENNSAID(®) (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%). 
PENNSAID 2% is a follow-on product to original PENNSAID (diclofenac sodium 
topical solution) 1.5% w/w (PENNSAID 1.5%) which has been marketed by 
Mallinckrodt in the U.S. since 2010. PENNSAID 2% will be the first twice per 
day dosed topical NSAID available in the U.S. for the treatment of the pain of 
osteoarthritis of the knee. Nuvo has licensed the U.S. sales and marketing 
rights for both PENNSAID 1.5% and PENNSAID 2% to Mallinckrodt. 
"The approval of PENNSAID 2% is a significant milestone for Nuvo," said Dan 
Chicoine, Chairman and Co-Chief Executive Officer of Nuvo Research. "We are 
pleased that the FDA has approved this product for patients suffering from the 
pain of osteoarthritis of the knee." 
PENNSAID (diclofenac sodium topical solution) 2% w/w 
PENNSAID (diclofenac sodium topical solution) 2% w/w is a nonsteroidal 
anti-inflammatory drug (NSAID) indicated for the treatment of pain 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   |

        --  PENNSAID is also contraindicated in patients:
      o with a known hypersensitivity to diclofenac sodium or any other
        component of PENNSAID
      o 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

        --  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
        --  Wash and dry hands before and after use. Avoid contact of
            PENNSAID with the eyes and mucous membrane.
        --  Do not:

apply PENNSAID to open wounds
               shower for at least 30 minutes after applying PENNSAID
               apply external heat and/or occlusive dressings to treated knees 

           wear clothing over the PENNSAID treated knee until the treated 
knee is dry 

        --  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

        --  The most common adverse events in a phase 2 clinical trial of
            PENNSAID 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 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%).

        --  PENNSAID should not be used in pregnant or lactating women and
            is not approved for use in pediatric patients.

About PENNSAID 1.5%

PENNSAID 1.5% is a non-steroidal anti-inflammatory drug (NSAID) used for 
treating the signs and symptoms of osteoarthritis of the knee(s).

PENNSAID 1.5% 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 

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


PENNSAID 2% is a follow-on product to original PENNSAID 1.5% 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 1.5%.  
It is more viscous than original PENNSAID 1.5%, is supplied in a metered dose 
pump bottle and has been approved for twice daily dosing compared to four 
times a day for original PENNSAID 1.5%.

About Nuvo Research Inc.
Nuvo (TSX:NRI) is a specialty pharmaceutical company focused on improving 
patient's lives by developing and commercializing innovative products that 
address unmet medical needs.  The Company has a diverse portfolio of products 
in the areas of topical pain and immunology.

Nuvo's marketed products include PENNSAID (a topical treatment for the signs 
and symptoms of osteoarthritis of the knee), PENNSAID 2% (a topical treatment 
for the pain of osteoarthritis of the knee), Pliaglis (a topical local 
anesthetic) and the heated lidocaine/tetracaine patch (HLT Patch).  For 
additional Company information visit

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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 
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SOURCE  Nuvo Research Inc. 
Christina Cameron Director, Investor Relations & Corporate Communications Tel: +1 (905) 673-3617   
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CO: Nuvo Research Inc.
ST: Ontario
-0- Jan/17/2014 12:00 GMT
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