Data Evaluating Synera® for the Treatment of Shoulder Impingement Syndrome
MISSISSAUGA, ON, April 19, 2013 /PRNewswire/ - Nuvo Research Inc. (TSX: NRI), a specialty pharmaceutical company dedicated to building a portfolio of products for the topical treatment of pain today announced that researchers presented scientific data related to Synera® (70 mg lidocaine/ 70 mg tetracaine) topical patch at the 22nd Annual Meeting of the American Medical Society for Sports Medicine (AMSSM) in San Diego, California. The data was a pooled analysis of two open label pilot studies of Synera in shoulder impingement syndrome (SIS) and showed that Synera provided clinically significant improvement of pain and function in SIS.
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 yet approved for the treatment of SIS and was used in the reported studies on an investigational basis.
"The data being presented at AMSSM demonstrates Nuvo's commitment to exploring the potential utility of the Synera Patch for new indications, and we are excited about the outcome from the pooled analysis of these two initial pilot studies," said Arnold Gammaitoni, Pharm.D., Vice President, Scientific Affairs at Nuvo.
"In these studies, treatment with Synera resulted in meaningful improvements in both range of motion and pain scores," said Richard Radnovich, D.O., principle investigator, Injury Care Medical Center, Boise, Idaho. "The patch topically delivers two medications into the local tissues with the assistance of heat and effectively delivers drugs to the musculoskeletal region causing the pain and dysfunction, while minimizing systemic exposure."
About the Studies
The data was pooled from two open-label, 14-day, pilot studies of Synera in patients with SIS. Both studies were conducted at the Injury Care Medical Center, Boise, Idaho. The studies included male and female patients at least 18 years of age with moderate to severe pain associated with SIS. Subjects applied a single Synera patch to the painful shoulder for 2-4 hours twice daily at approximately 12-hour intervals.
A total of 49 patients (25 female, 24 male) were included in the analysis. 84% of patients completed the studies. 70% of patients experienced a clinically meaningful reduction (≥30% reduction) in average pain scores. In addition, improvements were noted by reductions in pain interference with sleep, work, and general activity, as well as, improvements in range of motion in the affected shoulder. Approximately 76% of patients reported being "satisfied" or "very satisfied" with the treatment.
No serious adverse events were reported in either study. Application site erythema was the most common adverse event observed in 32 patients (65%). All cases of erythema were mild or moderate in severity and no patients withdrew from the studies due to erythema. Other application site reactions included skin irritation (n=2), pruritus (n=2), dermatitis (n=1), induration, (n=1), rash (n=1), swelling (n=1), urticaria (n=1), and bullous reaction (n=1). All were mild in severity, except the episode of dermatitis which was considered moderate in severity.
About the Poster
Treatment with the heated lidocaine/tetracaine patch improves pain and function in SIS - a pooled analysis of two prospective studies
Dr. Richard Radnovich, Injury Care Medical Center, Boise, ID, United
Poster Presentation: Friday, April 19, 2013
10:05am - 10:35am & 2:45pm - 3:15pm
- Poster #61
Shoulder impingement syndrome (SIS) is a common cause of shoulder pain and dysfunction and is typically caused by an impingement of the rotator cuff tendon. Persistent shoulder pain is a common reason for consulting with a primary care physician. Shoulder pain in adults aged <70 years is estimated to be between 7% and 27%. The goals of treatment are to reduce pain and improve function so patients may fully participate in physical rehabilitation. In addition to physical therapy, the two most common medications used to treatment pain in SIS are non-steroidal anti-inflammatory agents (NSAIDs) and corticosteroid injections.
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 occurred at the application site, including redness, blanching, and swelling. These reactions were generally mild and went away by themselves. Allergic reactions such as hives, difficulty breathing, skin redness or swelling, and shock can occur. Even a used Synera patch contains a large amount of lidocaine and tetracaine. A child or pet could suffer adverse effects from chewing or swallowing a new or used Synera patch; therefore, Synera should be stored and disposed out of their reach.
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 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 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 specialty 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 the compound WF10, for the treatment of immune related diseases.
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 Consolidated Financial Statements, Management's Discussion & Analysis, as well as in Nuvo's Annual Information Form for the year ended December 31, 2012. 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.
SOURCE Nuvo Research Inc.