Nuvo Pharmaceuticals™ Inc. Announces Results from European Ankle Sprain Study with Pennsaid® 2%
- Pennsaid 2% Already Approved for Osteoarthritis of the Knee in the United States -
MISSISSAUGA, ON, March 7, 2016 /PRNewswire/ - Nuvo Pharmaceuticals Inc. (TSX:NRI) (Nuvo or the Company) today announced top line results from its multi-centre, randomized, placebo-controlled, double-blind, parallel group trial in patients, with grade I or II ankle sprains conducted in Germany (the Trial).
The Study
The Trial enrolled 126 patients (the full analysis set or FAS) of which 116 patients followed the protocol (the per protocol set or PP). The patients enrolled in the Trial applied either Pennsaid 2% or a placebo consisting of a topical vehicle that included all of the constituent ingredients of Pennsaid 2%, except its active ingredient diclofenac sodium, to their injured ankle twice a day for 8 days. Randomly assigned double-blind treatment was started after baseline evaluation within 12 hours after injury (Day 1); the patients returned to the investigational site for in-depth evaluation on days 3, 5 and 8 of treatment. Results were tabulated for both the FAS and PP groups.
Primary Endpoint
The primary endpoint for the Trial was reduction in pain on movement (POM) at day 5 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. placebo was statistically significant on the secondary time point on day 3 (p=0.0119), but not at the primary time point on day 5 (p=0.2430) or the secondary time point on day 8 (p=0.2603). In the PP group, which excluded those patients with a lower usage of medication than as set out in the Trial protocol (9 patients excluded out of 126 for this reason), the Pennsaid 2% group showed a statistically significant improvement at both the primary time point (day 5 p=0.0416), as well as the secondary time points (day3 p=0.0018 and day 8 p=0.0490).
Secondary Endpoints
The Trial also included the measure of a number of secondary endpoints. These data are supportive of Pennsaid 2% being effective to treat ankle sprain injuries and specifically showed the following outcomes:
Tenderness - Pennsaid 2% demonstrated a statistically significant reduction in tenderness compared to placebo in the FAS group at days 3, 5 and 8 with p-values of 0.0055, 0.0150 and 0.0104, respectively.
Ankle Function - Pennsaid 2% demonstrated a statistically significant increase in ankle function compared to placebo in the FAS group at days 3 and 8 with p-values of 0.0115 and 0.0232, respectively, but not at day 5 with a p-value of 0.1549.
Ankle Swelling - Pennsaid 2% demonstrated a statistically significant decrease in ankle swelling compared to placebo in the FAS group at days 3, 5 and 8 with p-values of 0.0020, 0.0018 and 0.0142, respectively.
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 placebo in the FAS group with a p-value of 0.0001 for the treatment benefit and a p-value of <0.0001 for satisfaction.
Purpose of the Trial
Pennsaid 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). 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 Steps
The Company will be reviewing the Trial results in more detail and meeting with its consultants and with regulators to determine what steps, if any, are needed to obtain regulatory approval 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) nor will it impact the Company's efforts to out-license Pennsaid 2% in other jurisdictions.
"We are encouraged by the results of this first study of Pennsaid 2% for the treatment of ankle sprains," commented John London, President and CEO of Nuvo. "Although the study did not achieve its primary endpoint at day 5, we saw statistically significant reductions in pain on movement scores at day 3 and also at days 3, 5 and 8 in the 116 patients who followed protocol. The positive results on pain on movement score reduction were further reinforced by positive results for the majority of secondary endpoints which also demonstrated a statistically significant benefit with Pennsaid 2% treatment. We remain committed to our goal of making Pennsaid 2% a global brand and believe these data will be beneficial in our ongoing partnering discussions in key ex-U.S. territories."
About Pennsaid 2%
Pennsaid 2% is a topical product containing 2% diclofenac sodium compared to 1.5% for original Pennsaid. It is approved in the U.S. for pain of OA of the knee(s). It is more viscous than Pennsaid, is supplied in a metered dose pump bottle and has been approved in the U.S. for twice daily dosing compared to four times a day for Pennsaid. 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. Pennsaid 2% has not yet received regulatory approval outside of the U.S. Patents protecting Pennsaid 2% have been issued or are pending in multiple major international territories.
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 licensed GMP facility in Varennes, Québec.
For additional information, please visit www.nuvopharmaceuticals.com.
Forward-Looking Statements
Certain statements in this press release constitute forward-looking information and/or forward-looking statements (collectively, "forward-looking statements") within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, the future approval, marketing and sale of Pennsaid 2% in certain jurisdictions, 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 "may", "will", "expect", "intend", "believe", "should" or "plans", 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, but are not limited to, general business and economic uncertainties and adverse market conditions; as well as other risk factors included in the Company's Management Information Circular dated December 31, 2015 and the Company's Annual Information Form dated February 17, 2016 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. 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. Although the forward-looking information contained in this press 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. All forward-looking statements in this press release are qualified by these cautionary statements. The forward-looking statements contained herein are made as of the date of this press 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 Pharmaceuticals Inc.
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