PENNSAID - a topical NSAID - is indicated for the treatment of the signs and symptoms of osteoarthritis of the knee(s)
MISSISSAUGA, ON, April 27 /PRNewswire-FirstCall/ - Nuvo Research Inc. (TSX: NRI), a drug development company focused on the research and development of drug products that are delivered to and through the skin using its topical and transdermal drug delivery technologies, and on the development of its immune modulating drug candidate WF10, today announced that PENNSAID(R) (diclofenac sodium topical solution) 1.5% w/w, is now available by prescription in U.S. pharmacies.
PENNSAID is a non-steroidal anti-inflammatory drug (NSAID) indicated for the treatment of the signs and symptoms of osteoarthritis of the knee(s). Nuvo's U.S. licensee, Mallinckrodt Inc., a Covidien (NYSE: COV) company, has now commenced U.S. commercialization activities for PENNSAID. Nuvo will receive royalties on net U.S. sales of PENNSAID at rates that are consistent with industry standards. Nuvo will also be eligible to receive sales milestone payments totaling up to US$100 million as U.S. annual sales levels are achieved.
Nuvo develops drug products delivered to and through the skin using its topical and transdermal drug delivery technologies. Covidien is the largest supplier of controlled pain medications in the United States based on number of prescriptions.
"Physicians in the United States now have a new alternative to help patients manage their signs and symptoms of osteoarthritis of the knee," said Dr. Brad Galer, President of Nuvo Research's Pain Group. "Covidien's commercial launch of PENNSAID in the U.S. is the culmination of our attainment of U.S. Food and Drug Administration approval, and the establishment of a strong collaboration with an exceptional sales and marketing organization in Covidien. The launch of PENNSAID in the U.S. should further strengthen Nuvo financially and support the Company's continued growth as a leader in the development of new pain medications."
About Nuvo Research Inc.
Nuvo is primarily focused on the research and development of drug products delivered to and through the skin using its topical and transdermal drug delivery technologies, and on the development of its immune modulating drug candidate WF10. Nuvo's lead product is PENNSAID, a topical non-steroidal anti-inflammatory drug (NSAID), which is sold in Canada, several European countries and now the United States. PENNSAID was approved for marketing in the U.S. by the FDA on November 4, 2009. Nuvo intends to leverage its skin-penetrating technologies to create a portfolio of topical and transdermal products targeting a variety of indications. Nuvo is a publicly traded, Canadian pharmaceutical company headquartered in Mississauga, Ontario. Nuvo's Pain Group is located in West Chester, Pennsylvania. Its manufacturing facilities are located in Varennes, Quebec and Wanzleben, Germany, and its research and development centers are located in San Diego, California and Leipzig, Germany. For more information, please visit www.nuvoresearch.com.
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.
Please click the link below for Full Prescribing Information and 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, 2009. 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
IMPORTANT RISK INFORMATION ABOUT PENNSAID ------------------------------------------------------------------------- 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. ------------------------------------------------------------------------- PENNSAID is 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.
SOURCE Nuvo Research Inc.