Nuvo Research® Announces Scientific Presentations at Annual Painweek 2013 Meeting

Nuvo Research® Announces Scientific Presentations at Annual Painweek 2013 
Data Evaluating Heated Lidocaine/Tetracaine Patch for the Treatment of Acute 
Musculoskeletal Pain to be Presented 
MISSISSAUGA, ON, Sept. 5, 2013 /CNW/ - Nuvo Research Inc. (TSX: NRI), a 
specialty pharmaceutical company dedicated to building a portfolio of products 
for the topical treatment of pain and the development of its immune modulating 
drug candidate WF10 announced today that researchers are presenting scientific 
data related to the heated lidocaine/tetracaine patch (HLT Patch) (70 mg 
lidocaine/ 70 mg tetracaine) at PAINWeek 2013, to be held September 4-7 in Las 
The current marketed version of the HLT Patch, known as the Synera Patch, is 
FDA approved 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. The Synera 
Patch is currently marketed in the United States by Nuvo's exclusive licensing 
partner for the current approved indication, Galen US Incorporated (Galen). 
The HLT Patch is being developed by Nuvo for the treatment of acute 
musculoskeletal pain (AMP). 
Study 1 
The study in the first poster was conducted to compare 2 different dosing 
application regimens of the HLT Patch (twice daily and once daily application) 
and oral naproxen for the treatment of pain associated with lateral 
epicondylitis (tennis elbow) in a 4-week open-label study that enrolled 52 
adult subjects. After 2 weeks of treatment, clinically important reduction 
in average pain scores (defined as ≥30% reduction from baseline) were 
experienced by more patients treated with the HLT Patch 4 hr BID (56%) and the 
HLT Patch 12 hr QD (53%) than by patients treated with oral naproxen (41%). 
Application site rash or erythema was reported by 50% of patients in the HLT 
Patch twice daily application group and 18% of patients in the HLT Patch once 
daily application group. Two patients in the HLT Patch twice daily application 
group withdrew from the study due to application site adverse events. Two 
patients in oral naproxen group experienced nausea as an adverse event. 
"In this study the HLT Patch administered once or twice daily for pain of 
lateral epicondylitis resulted in the majority of patients experiencing 
clinically meaningful reductions in pain comparable to that seen with oral 
naproxen. The HLT Patch may offer a novel significant clinical option by 
providing a locally targeted treatment which minimizes the risks of systemic 
adverse effects for patients with tennis elbow pain," said Srinivas Nalamachu, 
MD, principal investigator, International Clinical Research Institute Inc., 
Overland Park, KS. 
Study 2 
The study in the second poster compared the efficacy of the HLT Patch vs a 
single corticosteroid injection for the treatment of shoulder impingement 
syndrome (SIS) pain in a 6-week, randomized, open-label study which enrolled 
60 adult subjects. Both groups demonstrated a significant (P<.001) reduction 
in average pain scores at 2 weeks compared with baseline (-35%±29% and 
-42%±36% in the HLT Patch and injection groups, respectively), which were 
sustained through 6 weeks (-43%±34% and -43%±41%, respectively). 
Significant improvements in shoulder range of motion were also seen in both 
treatment groups by treatment week 2 and sustained throughout the entire 6 
week study. Mild to moderate application site erythema was the most common 
treatment related adverse event observed in 22 of 29 HLT Patch patients. 
"In this study, the HLT Patch 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. 
Study 3 
The third poster will be presenting a pooled analysis that examined the 
relationship between decreased pain scores and improved function in 73 
subjects treated with HLT Patch in four open-label pilot studies for AMP 
associated with SIS, patellar tendinopathy, carpal tunnel syndrome and 
myofascial trigger points. Approximately one third of patients treated with 
the HLT Patch achieved a ≥50% reduction in average pain scores, which was 
also associated with 1.5- to 2-fold greater functional improvement. 
"A number of recent publications have suggested that a 50% or greater 
improvement in pain be considered as "substantial." Here we see that this 
level of pain improvement is associated with a twofold greater degree of 
functional improvement underscoring this as an important measure of a 
treatment's effectiveness," said Arnold Gammaitoni, Pharm.D., Vice President, 
Scientific Affairs at Nuvo. 
Important Risk Information for the current marketed formulation 
In clinical studies with the current marketed formulation, 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. The Synera Patch 
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 
The current formulation is contraindicated in patients with a known history of 
sensitivity to lidocaine, tetracaine, or local anesthetics of the amide or 
ester type. The current formulation 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 for the current formulation at for 
additional Important Risk Information. 
About Nuvo Research Inc. 
Nuvo (TSX:NRI) is a specialty pharmaceutical company focused on improving 
patient's lives by developing and commercializing innovative products that 
address unmet medical needs. The Company has a diverse portfolio of products 
in the areas of topical pain and immunology. 
Nuvo's marketed products include Pennsaid(®) (a topical treatment for the 
signs and symptoms of osteoarthritis of the knee), Pliaglis (a topical local 
anesthetic) and the heated lidocaine/tetracaine patch (HLT Patch). For 
additional Company information visit 
Forward-Looking Statements 
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forward-looking statements reflect management's current beliefs and are based 
on information currently available to management. Forward-looking statements 
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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 
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assumes responsibility for the accuracy and completeness of these 
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SOURCE  Nuvo Research Inc. 
Investor Relations 
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