Zorvolex Approved by FDA for Treatment of Osteoarthritis Pain

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1 Zorvolex Approved by FDA for Treatment of Osteoarthritis Pain Am J Orthop September;43(9) Authors: Author Affiliation Disclosures Iroko Pharmaceuticals (Philadelphia, Pennsylvania) announced that the FDA has approved Zorvolex (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID) for the management of mild to moderate acute pain and osteoarthritis pain. This marks the second indication for the drug, which was approved by the FDA in October 2013 for treatment of mild to moderate acute pain in adults. Zorvolex was created to align with recommendations from the FDA and several medical organizations that NSAIDs be used at the lowest effective dose and for the shortest possible duration. This low-dose NSAID was developed using SoluMatrix Fine Particle Technology. Zorvolex contains diclofenac as submicron particles that are approximately 20 times smaller than their original size. The reduction in particle size provides an increased surface area, which leads to faster dissolution. NSAIDs continue to be an integral part of the management for osteoarthritis and their use is likely to increase as the US population continues to age and the incidence of osteoarthritis rises, said Roy Altman, MD, Professor of Medicine in Rheumatology at UCLA. The approval of Zorvolex is supported by data from a 12-week multicenter, randomized, double-blind, parallelgroup, placebo-controlled study. The study included 305 patients aged 41 to 90 years with osteoarthrisis of the knee or hip. Half of the patients were between the ages of 61 and 90 years. They were randomized to 35 mg of Zorvolex three times a day, 35 mg twice daily, or placebo. The Supplemental New Drug Application also included data from a 12-month open-label safety study of 602 patients. Zorvolex is available in 18 mg or 35 mg capsules. The approval of Zorvolex is a welcome and meaningful advance and is the first SoluMatrix NSAID option approved by the FDA for osteoarthritis pain, Dr. Altman stated. References Top Articles Hip // Imaging A Three-View Radiographic Approach to Femoroacetabular Impingement Sep 2018 The American Journal of Orthopedics 1

2 Hip // Trauma Time-to-Surgery for Definitive Fixation of Hip Fractures: A Look at Outcomes Based Upon Delay 5 Points on Meniscal Allograft Transplantation Sep 2018 The American Journal of Orthopedics 2

3 Shoulder & Elbow // Trauma Case Series Evaluating the Operative and Nonoperative Treatment of Scapular Fractures Epidemiology of Existing Extensor Mechanism Pathology in Primary Anterior Cruciate Ligament Ruptures in an Active-Duty Population Hip // Imaging A Three-View Radiographic Approach to Femoroacetabular Impingement Sep 2018 The American Journal of Orthopedics 3

4 Hip // Trauma Time-to-Surgery for Definitive Fixation of Hip Fractures: A Look at Outcomes Based Upon Delay 5 Points on Meniscal Allograft Transplantation Sep 2018 The American Journal of Orthopedics 4

5 Shoulder & Elbow // Trauma Case Series Evaluating the Operative and Nonoperative Treatment of Scapular Fractures Epidemiology of Existing Extensor Mechanism Pathology in Primary Anterior Cruciate Ligament Ruptures in an Active-Duty Population Commentary Editorial Board Biographies Practice Management // Education Center Update on Internet-Based Orthopedic Registries Med4 Elite™ GRPro 2.1 Shoulder Wrap Sep 2018 The American Journal of Orthopedics 5

6 Wrap Citation. Zorvolex Approved by FDA for Treatment of Osteoarthritis Pain. Am J Orthop September;43(9). Zorvolex Approved by FDA for Treatment Sep 2018 The American Journal of Orthopedics 6