Nuvo Pharmaceuticals™ Inc. Announces Pennsaid 2% Phase 3 Trial to Support Regulatory Approvals in the E.U., Canada and Australia
July 13, 2016
MISSISSAUGA, ON, July 13, 2016 /CNW/ - Nuvo Pharmaceuticals Inc. (TSX:NRI) (Nuvo or the Company) today announced it will conduct a new placebo-controlled, multi-centre Phase 3 trial (Trial) in Germany to study Pennsaid 2% for the treatment of acute ankle sprains. Topline results of the Trial are expected to be available in late Q2 or early Q3 2017. The Trial is subject to approval by German regulatory authorities and the ethical review committee. Pennsaid 2% is currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of the pain of osteoarthritis of the knee(s). The Trial will be conducted to support regulatory applications for marketing approval of Pennsaid 2% for the treatment of acute pain in the E.U., Canada and Australia. 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. The Trial will cost approximately CDN$1.5 million spread over the second half of 2016 and the first half of 2017. The Company believes that potential revenue to be generated by the Trial far exceeds its modest cost.
"The Trial incorporates what we learned from a similar trial that we conducted in 2015 that produced encouraging results and we believe that Pennsaid 2% can show positive results in this setting," said John London, Nuvo's President and CEO. "In particular, we have changed the primary endpoint (pain on movement) to the third day after initial treatment which was a secondary endpoint at which Pennsaid 2% demonstrated statistical significance in the 2015 trial."
About the Trial
The Trial will be conducted in Germany and will enroll approximately 130 patients who have suffered a grade I or grade II ankle sprain as assessed by the investigator within 12 hours of injury. Patients will then be randomly assigned on a double-blind basis to an active arm or a placebo arm and will apply either Pennsaid 2% or a placebo consisting of a topical vehicle that includes all of the constituent ingredients of Pennsaid 2%, except its active ingredient diclofenac sodium, to their injured ankle twice a day for 8 days. The patients will return to the investigational site for in-depth evaluation on days 3, 5 and 8 of treatment. The primary endpoint for the Trial will be reduction in pain on movement (POM) at day 3. The Trial will measure a number of secondary endpoints including tenderness, ankle function, ankle swelling, overall assessment of benefit and satisfaction and use of rescue medication.
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). 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 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. 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, Health Canada and EU approved manufacturing facility in Varennes, Québec. For additional information, please visit www.nuvopharmaceuticals.com.
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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