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Nuvo Research Inc. (NRI.TO) Announces Scientific Presentations at Annual Painweek 2013 Meeting


9/5/2013 7:16:08 AM

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Data Evaluating Heated Lidocaine/Tetracaine Patch for the Treatment of Acute Musculoskeletal Pain to be Presented

MISSISSAUGA, ON, Sept. 5, 2013 /PRNewswire/ - 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 Vegas.

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 pets.

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 www.synera.com 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 www.nuvoresearch.com.

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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