Press Release Source: Nuvo Research inc. On Wednesday September 14, 2011, 7:00 am EDT
MISSISSAUGA, ON, Sept. 14, 2011 /PRNewswire/ – Nuvo Research inc. (TSX:NRI.to – News), 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. marketing partner, Mallinckrodt inc., a Covidien company (NYSE:COV – News), has announced that they intend to pursue the Supplementary new Drug Application (sNDA) regulatory approval pathway for PENNSAID® Viscous Solution instead of using the 505(b)(2) pathway for new drug approval, as previously planned. Covidien has advised Nuvo that it believes the data obtained through its recently completed clinical study can be used to support the sNDA. Covidien has also advised Nuvo that an sNDA could be filed with the United States Food and Drug Administration (FDA) sooner, that the FDA review cycle is expected to be shorter and that PENNSAID Viscous Solution could therefore be approved more quickly than if Covidien follows the 505(b)(2)pathway.
About PENNSAID Viscous Solution
PENNSAID Viscous Solution 2% w/w is a higher viscosity formulation of PENNSAID (diclofenac sodium topical solution) 1.5% w/w. PENNSAID is an FDA approved, topical non-steroidal anti-inflammatory drug (NSAID) indicated for the treatment of the signs and symptoms of osteoarthritis (OA) of the knee(s). PENNSAID Viscous Solution is currently in development for the treatment of the signs and symptoms of OA of the knee(s) via twice-daily administration with a 2% diclofenac concentration.
The development of PENNSAID Viscous Solution in the United States is being handled by Nuvo’s licensee, Covidien, pursuant to the terms of the 2009 license agreement (Agreement) between the parties. under the Agreement, Covidien has assumed all responsibility for managing, executing and paying for all development activities for PENNSAID Viscous Solution.
About Nuvo Research inc.
Nuvo Research 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 and by in-licensing and acquisition. The Company’s Pain Group, located in West Chester, Pennsylvania, is focused on the development and commercialization of topically delivered pain products. The Company’s product portfolio includes PENNSAID, Pliaglis and Synera. PENNSAID, a topical non-steroidal anti-inflammatory drug (NSAID), is used to treat the signs and symptoms of osteoarthritis of the knee. PENNSAID is sold in the United States by Mallinckrodt inc., a Covidien company (NYSE:COV – News), in Canada by Paladin Labs inc. (TSX:PLB.to – News) and in several European countries. Pliaglis is a topical local anesthetic cream, which is U.S. Food and Drug Administration (FDA) approved to provide topical local analgesia for superficial dermatological procedures. The Company has licensed worldwide marketing rights to Pliaglis to Galderma Pharma S.A., a global specialty pharmaceutical company focused on dermatology. Synera is a topical patch that combines lidocaine, tetracaine and heat, approved in the United States to provide local dermal analgesia for superficial venous access and superficial dermatological procedures and in Europe, for surface anaesthesia of normal intact skin. Nuvo currently markets Synera in the United States and its licensing partner, EuroCept International B.V., has initiated a pan-European launch of Synera (under the name Rapydan) in several European countries. through its subsidiary, Nuvo Research GmbH, based in Leipzig, Germany, the Company is also developing the compound WF10, for the treatment of immune related diseases. For more information, please visit www.nuvoresearch.com.
IMPORTANT RISK INFORMATION ABOUT PENNSAID
- Non-steroidal 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.
- 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 anaphylactic-like 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.
Should not be used in pregnant or lactating women and is not approved for use in pediatric patients.
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.
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%).
Do not apply to open wounds. Protect treated knee(s) from natural or artificial sunlight. Topicals such as sunscreen and bug repellant 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.
See Full Prescribing Information for additional Important Risk Information.
This document contains forward-looking statements. some forward-looking statements may be identified by words like “expects”, “anticipates”, “plans”, “intends”, “indicates” or similar expressions. these forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Nuvo considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but caution that these assumptions regarding future events, many of which are beyond the control of the Company, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations, are discussed in the annual report, as well as in Nuvo’s Annual Information Form for the year ended December 31, 2010. Nuvo disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law. For additional information on risks and uncertainties relating to these forward looking statements, investors should consult the Company’s ongoing quarterly filings, annual report and Annual Information Form and other filings found on SEDAR at www.sedar.com.