Nuvo Research, a specialty pharmaceutical company with a diverse portfolio of topical and immunology products, has announced that it is planning to commence a phase 3 clinical study of Pennsaid 2% for the treatment of acute pain to support regulatory approval applications for Pennsaid 2% in international jurisdictions.
The study will be conducted in Germany to assess the efficacy of Pennsaid 2% for the relief of pain associated with acute, localized muscle or joint injuries such as sprains, strains or sports injuries. Commencement of the study, which is subject to German regulatory approval, is expected in Q2 2015 with top-line results expected in Q4 2015.
The study will cost approximately CDN$1.5 million.“This phase 3 study will support regulatory approval in many jurisdictions, including the European Union and is an integral part of our plan to seek a partner or partners to market Pennsaid 2% internationally and make Pennsaid 2% a global brand,” said Dan Chicoine, Nuvo’s chairman and co-chief executive officer. “While the global topical NSAID market is competitive, we believe that Pennsaid 2%’s superior product attributes make it a very desirable asset for potential licensees.”
The phase 3 study will be a randomised, double-blind, placebo-controlled study evaluating the efficacy and safety of Pennsaid 2% for the relief of pain associated with recent (acute), localised muscle or joint injuries such as sprains, strains or sports injuries. The primary endpoint will be change in pain on movement (POM) from day 1 to day 5. It will also measure other secondary endpoints.
Pennsaid 2% is a topical product containing 2% diclofenac sodium compared to 1.5% for original Pennsaid. It is approved in the US for pain of osteoarthritis(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 US for twice daily dosing compared to four times a day for Pennsaid.
Pennsaid 2% is protected by 6 US 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 US Patents protecting Pennsaid 2% have been issued or are pending in multiple major international territories.