NUVO RESEARCH ANNOUNCES POSITIVE TOP-LINE RESULTS FOR PENNSAID VISCOUS SOLUTION PHASE 2 TRIAL
June 30, 2011
MISSISSAUGA, ON, June 30, 2011 /CNW/ - Nuvo Research Inc. (TSX: NRI), a specialty pharmaceutical company dedicated to building a portfolio of products primarily for the treatment of pain, today announced receipt from Mallinckrodt Inc., a Covidien company (Covidien), of top-line results from a Phase 2 study conducted by Covidien, of twice-daily administration of PENNSAID® Viscous Solution (topical diclofenac sodium viscous solution) 2% w/w, previously referred to as PENNSAID Gel. The study met its primary endpoint of reducing osteoarthritis (OA) pain greater than a placebo vehicle control (p=0.042).
"We are pleased with the top-line results of this Phase 2 clinical trial for PENNSAID Viscous Solution," said Dr. Bradley S. Galer, President, Pain Group of Nuvo Research. "We look forward to receiving the detailed results from this study in the future and working with Covidien to obtain FDA approval for PENNSAID Viscous Solution."
The Phase 2 study was a four-week, two-arm, double-blind, vehicle-controlled, parallel, randomized trial. The primary endpoint was the effect of PENNSAID Viscous Solution vs. placebo vehicle control on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®) pain from baseline to four weeks. The study enrolled 259 subjects who were either administered PENNSAID Viscous Solution or a placebo vehicle control for the duration of the study. There were no significant differences in subject retention, demographics or baseline characteristics between the two study arms. The most common adverse event in both groups was application site dryness (21.5% and 21.7%).
OA is one of the most common forms of degenerative joint disease. In the U.S., approximately 27 million adults aged 25 and older suffer from clinical OA. In adults, arthritis is one of the leading causes of disability and is among the most common conditions resulting in work limitations. OA of the knee is the most frequent form of lower extremity arthritis and contributes to about 418,000 knee replacement procedures annually.
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 a United States Food and Drug Administration (FDA) approved, topical non steroidal anti-inflammatory drug (NSAID) indicated for the treatment of the signs and symptoms of 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 Research'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 NSAID, is used to treat the signs and symptoms of OA of the knee(s). PENNSAID is sold in the United States by Mallinckrodt Inc., a Covidien company (NYSE: COV), in Canada by Paladin Labs Inc. (TSX:PLB) and in several European countries. Pliaglis is a topical local anesthetic cream, which is 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 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
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