Nuvo Research Announces FDA Approval of PENNSAID« 2%

20 January 2014

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

 

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

WARNINGS AND PRECAUTIONS

               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

ADVERSE REACTIONS

USE IN SPECIFIC POPULATIONS

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

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 datedMarch 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.

 

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