OREANDA-NEWS. 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."

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.