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Data Evaluating Synera® for the Treatment of Acute Musculoskeletal Pain to be Presented at the Scientific Meeting
MISSISSAUGA, ON, May 30, 2013 /PRNewswire/ - Nuvo Research Inc. (TSX: NRI), a specialty pharmaceutical company dedicated to building a portfolio of products for the topical treatment of pain announced that researchers presented scientific data related to the Synera (70 mg lidocaine/ 70 mg tetracaine) topical patch at the 60th Annual Meeting of the American College of Sports Medicine in Indianapolis, Indiana.
Synera is a topical patch that is approved in the United States and Europe for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodessication and shave biopsy of skin lesions. Synera is not approved for the treatment of shoulder impingement syndrome (SIS) or acute musculoskeletal pain (AMP) in any country and was used in the reported studies on an investigational basis.
About Study 1
The study for the first Poster compared the effectiveness of Synera versus corticosteroid injection in the treatment of SIS pain in a 6-week, open-label study that enrolled sixty patients. Approximately 83% of patients in the Synera group demonstrated a clinically meaningful reduction in average pain intensity score (30% reduction) compared with approximately 77% in the injection group. Both groups achieved significant clinically meaningful improvements in shoulder range-of-motion measures. Mild to moderate application site erythema was the most common treatment related adverse event observed in 22 of 29 Synera patch patients.
“In this study, Synera provided similar degrees of improvement in both pain and range of motion, when compared to the current gold-standard treatment of steroid injection. Being able to treat shoulder impingement effectively, while avoiding the potential problems of steroids and injections, is a significant clinical advantage,” said Richard Radnovich, D.O., principle investigator, Injury Care Medical Center, Boise, Idaho.
About Study 2
The second Poster presented a pooled analysis that examined the relationship between decreased pain scores and improved function in 73 subjects treated with Synera in four open-label pilot studies for AMP associated with SIS, patellar tendinopathy, carpal tunnel syndrome or myofascial trigger points. After 14 days of treatment with Synera, there was a strong correlation between the percent improvement in pain score with the percent improvement in function, pain interference scores for general activity, work, and sleep. The most common adverse events were mild to moderate erythema (30%), pruritus (11%), and rash (5%).
“In the patients treated with Synera, a reduction in pain was accompanied by functional improvement, as well as improvement in activity, work and sleep, demonstrating Synera’s potential benefit in treating AMP,” said Arnold Gammaitoni, Pharm.D., Vice President, Scientific Affairs at Nuvo Research Inc.
About Synera
Synera (lidocaine 70 mg/tetracaine 70 mg) topical patch is a combination amide and ester local anesthetic topical patch indicated for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodessication and shave biopsy of skin lesions.
Important Risk Information
In clinical studies, the most common skin reactions were generally mild application site reactions such as redness, blanching, and swelling. Allergic reactions such as hives, difficulty breathing, skin redness or swelling, and shock can occur. Synera should be stored and disposed out of their reach since large amounts of lidocaine and tetracaine remain in the patch and can be harmful to children or pets.
Synera is contraindicated in patients with a known history of sensitivity to lidocaine, tetracaine, or local anesthetics of the amide or ester type. Synera is also contraindicated in patients with para-aminobenzoic acid (PABA) hypersensitivity and in patients with a known history of sensitivity to any other component of the product.
See Full Prescribing Information at www.Synera.com for additional Important Risk Information.
About Nuvo Research Inc.
Nuvo 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. The Company’s product portfolio includes Pennsaid®, Pliaglis and Synera®. Pennsaid, a topical nonsteroidal anti-inflammatory drug (NSAID), is used to treat the signs and symptoms of osteoarthritis of the knee(s). Pennsaid is sold in the United States by Mallinckrodt Inc., a Covidien company, in Canada by Paladin Labs Inc. and in several European countries. Pliaglis is a topical local anesthetic cream which provides topical local analgesia for superficial dermatological procedures. The Company has licensed worldwide marketing rights to Pliaglis to Galderma Pharma S.A., a global pharmaceutical company specialized in 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. The Company is also developing WF10, for the treatment of immune related diseases.
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 dated March 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.
SOURCE Nuvo Research Inc.
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