Nuvo Research Announces FDA Approval of PENNSAID® 2%

MISSISSAUGA, ON, Jan. 17, 2014 /PRNewswire/ - 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

INDICATIONS AND USAGE

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).

IMPORTANT RISK INFORMATION

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 anaphylactic-like 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.
• 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 conducted.

ADVERSE REACTIONS

• 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%).

USE IN SPECIFIC POPULATIONS

• 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 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 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 www.nuvoresearch.com.

Forward-Looking Statements

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