Data Evaluating Synera® for the Treatment of Acute Musculoskeletal Pain to be Presented at the
MISSISSAUGA, ON, May 30, 2013 /CNW/ - 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
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
"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.
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.
Certain statements in this news release constitute forward-looking
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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
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SOURCE: Nuvo Research Inc.
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