Nuvo Pharmaceuticals™ Inc. Announces Topline Results from European Ankle Sprain Study with Pennsaid® 2%

Monday, May 15, 2017 Drug News
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- Pennsaid 2% Already Approved for Marketing in the United States and Russia -

MISSISSAUGA, ON,

May 15, 2017 /PRNewswire/ - Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX:NRI), a commercial healthcare company with a portfolio of commercial products and pharmaceutical manufacturing capabilities, today reported
topline results from its multi-centre, randomized, placebo-controlled, double-blind, parallel group trial in patients, with grade I or II ankle sprains (the Trial) and in particular reported that the Trial had failed to meet its primary endpoint.

The TrialThe Trial was conducted in Germany and enrolled 134 patients (the full analysis set or FAS) of which 122 patients followed the protocol (the per protocol set or PP) who had suffered a grade I or grade II ankle sprain as assessed by the investigator within 12 hours of injury.  Patients were randomly assigned on a double-blind basis to an active arm or a control arm and applied either Pennsaid 2% or a control consisting of a topical vehicle that includes all the constituent ingredients of Pennsaid 2%, except its active ingredient diclofenac sodium (the Control) to their injured ankle twice a day for 8 days.  The patients returned to the investigational site for in-depth evaluation on days 3, 5 and 8 of treatment.  The primary endpoint for the Trial was reduction in pain on movement (POM) at day 3.  The Trial also measured a number of secondary endpoints including ankle function, meaningful improvement in pain on movement, overall assessment of benefit and satisfaction, tenderness and ankle swelling.  Patients also filled out a daily diary that recorded their answers to a number of standardized questions related to the negative impact of the injury on sleep and daily activities.  The Trial commenced in November 2016 and was fully enrolled in March 2017. 

Primary EndpointThe primary endpoint for the Trial was reduction in pain on movement (POM) at day 3 in the FAS group.  On average, patients treated with Pennsaid 2% had a larger reduction in POM scores over the course of the study.  For the FAS group, the difference vs. Control was not statistically significant at the primary time point at day 3 (p=0.5074) or the secondary time point at day 5 (p=0.1642); however, was statistically significant at the secondary time point at day 8 (p=0.0099).  In the PP group, the Pennsaid 2% group did not show a statistically significant improvement at day 3 (p=0.6996) or day 5 (p=0.1865), but did show a statistically significant improvement at day 8 (p=0.0154).

Secondary EndpointsThe Trial also included the measure of a number of secondary endpoints.  

Ankle Function - Pennsaid 2% demonstrated a statistically significant increase in ankle function compared to Control in the FAS group at days 3, 5 and 8 with p-values of 0.0383, 0.0072 and 0.0055, respectively.

Meaningful Improvement in POM - Pennsaid 2% demonstrated a statistically significant meaningful improvement in POM compared to Control in the FAS group at day 5 (p=0.0444) but not at day 3 (p=0.4127) or day 8 (p=0.0961).

Overall Assessment of Benefit and Satisfaction - Patients treated with Pennsaid 2% reported a statistically significantly higher level of satisfaction with and benefit of their treatment compared to Control in the FAS group at day 8 with a p-value of 0.0164 for the treatment benefit and a p-value of 0.0499 for satisfaction; however, did not report a statistically higher level of satisfaction and benefit of their treatment compared to Control at days 3 (p=0.2464 and p=0.1389 for benefit and satisfaction, respectively) or at day 5 (p=0.1974 and p=0.2548 for benefit and satisfaction, respectively)

Tenderness - Pennsaid 2% did not demonstrate a statistically significant reduction in tenderness compared to Control in the FAS group at days 3, 5 and 8 with p-values of 0.1776, 0.4870 and 0.9013, respectively

Ankle Swelling - Pennsaid 2% did not demonstrate a statistically significant decrease in ankle swelling compared to Control in the FAS group at days 3, 5 and 8 with p-values of 0.1150, 0.7980 and 0.1042, respectively.

Diary Entries –  The daily diary records in the morning (reflecting on the past night) indicated a distinct trend that pain had less negative impact on sleep quality (number of times waking up due to pain and worst intensity of pain experienced during the night) in the patients treated with Pennsaid 2%; similarly, the daily diary records in the evening (reflecting on the past day) indicated that Patients treated with Pennsaid 2% tended to experience less disabling pain during their daily activities than patients treated with Control.

Purpose of the TrialPennsaid 2% is currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of the pain of osteoarthritis (OA) of the knee(s).  It is also approved by the Russian Ministry of Health for non-prescription human use in treating back pain, joint pain, muscle pain, and inflammation and swelling in soft tissue and joints associated with trauma and rheumatic conditions. The Trial was conducted to support regulatory applications for marketing approval of Pennsaid 2% for the treatment of acute pain in the E.U., Canada and Australia which are potential new markets for Pennsaid 2%.  The Company believes that most other jurisdictions will base their marketing approval on existing data, including the current U.S. FDA approval of Pennsaid 2% and will not require additional clinical efficacy data.  

Next StepsThe Company will be reviewing the Trial results in more detail and meeting with its scientific advisors and regulatory consultants to determine what its next steps should be in relation to regulatory submissions of Pennsaid 2% in Canada, Australia and the E.U.

The Trial results will not affect the marketing and sale of Pennsaid 2% in the U.S. where it is approved by the FDA for the treatment of the pain of OA of the knee(s) or in Russia where it is approved for non-prescription human use of Pennsaid 2% in treating back pain, joint pain, muscle pain, and inflammation and swelling in soft tissue and joints associated with trauma and rheumatic conditions.

"We are obviously disappointed by the Trial results," commented John London, CEO of Nuvo. "Although the Trial did not achieve its primary endpoint of reduction in pain on movement at day 3, we saw positive indications in the secondary endpoints, as well as in the patient diaries that Pennsaid 2% is beneficial in the treatment of patients with ankle sprains.  We will continue to assess the opportunities available to us to pursue marketing authorizations for Pennsaid 2% in Canada, Australia and the E.U."

About Pennsaid 2%Pennsaid 2% is topical non-steroidal anti-inflammatory drug (NSAID) containing 2% diclofenac sodium.  It is approved by the FDA for treating the pain of osteoarthritis of the knee(s) and by the Russian Ministry of Health for non-prescription human use in treating back pain, joint pain, muscle pain, and inflammation and swelling in soft tissue and joints associated with trauma and rheumatic conditions.  Pennsaid 2% is a gel formulation that is supplied in a metered dose pump bottle.  It is the only topical NSAID approved by the FDA and by the Russian Ministry of Health for twice daily dosing.  Pennsaid 2% is protected by multiple U.S. patents that are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations database or Orange Book. Patents protecting Pennsaid 2% have been issued or are pending in multiple major international territories. Pennsaid 2% has not yet received regulatory approval outside of the U.S. and Russia. 

About Nuvo Pharmaceuticals Inc.Nuvo (TSX:NRI) is a commercial healthcare company with a portfolio of commercial products and pharmaceutical manufacturing capabilities.  Nuvo has three commercial products that are available in a number of countries; Pennsaid 2%, Pennsaid and the heated lidocaine/tetracaine patch.  Pennsaid 2% is sold in the U.S. by Horizon Pharma plc (NASDAQ:HZNP) and is available for partnering in certain other territories around the world.  Nuvo manufactures Pennsaid for the global market and Pennsaid 2% for the U.S. market at its FDA, Health Canada and E.U. approved manufacturing facility in Varennes, Québec.  For additional information, please visit www.nuvopharmaceuticals.com.

Forward-Looking Statements This Press Release contains "forward-looking statements" within the meaning of applicable securities laws. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods.

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on the Company's current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. Nuvo's actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, readers should not rely on any of these forward-looking statements. Important factors that could cause Nuvo's actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the risk factors included in Nuvo's most recent Annual Information Form dated March 1, 2017 under the heading "Risks Factors", and as described from time to time in the reports and disclosure documents filed by Nuvo with Canadian securities regulatory agencies and commissions. These and other factors should be considered carefully and readers should not place undue reliance on Nuvo'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 none of Nuvo or any other person assumes responsibility for the accuracy and completeness of these forward-looking statements.

Any forward-looking statement made by the Company in this Press Release is based only on information currently available to it and speaks only as of the date on which it is made. Except as required by applicable securities laws, Nuvo undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

SOURCE Nuvo Pharmaceuticals Inc.



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