Low-dose SoluMatrix diclofenac: a review of safety across two Phase III studies in patients with acute and osteoarthritis pain

Abstract

Introduction: Similar to other NSAIDs, diclofenac is associated with serious dose-related cardiovascular, gastrointestinal, and renal adverse events. Low-dose SoluMatrix diclofenac, containing submicron particles of diclofenac, was developed to provide effective analgesia at lower drug doses compared with currently available NSAIDs.

Areas covered: The efficacy and safety of low-dose SoluMatrix diclofenac was evaluated in two randomized, placebo-controlled Phase III studies: a study in patients with acute pain following bunionectomy surgery and a study in patients with osteoarthritis pain of the hip or knee. In this review article, we summarize safety data from these studies.

Expert opinion: The safety results from the Phase III studies indicate that all dosing regimens of low-dose SoluMatrix diclofenac up to 12 weeks are generally well tolerated. Few serious gastrointestinal, cardiovascular, renal, or hepatic adverse events commonly associated with NSAID use were reported in these studies. Although not directly compared, the safety of SoluMatrix diclofenac was similar to findings for other diclofenac drug products. The potential for safe and effective management of acute and chronic pain at reduced NSAID doses is attractive; definitive characterization of SoluMatrix diclofenac safety requires confirmation by long-term studies.

Keywords:

• acute pain
• diclofenac
• osteoarthritis
• safety
• SoluMatrix

Acknowledgments

Medical writing support was provided by Ewa Wandzioch, PhD; Jennifer Tyson, PhD; and Colville Brown, MD (AlphaBioCom LLC, King of Prussia, PA); and funded by Iroko Pharmaceuticals, LLC.

Declaration of interest

C Young and EO Imasogie are employees of Iroko Pharmaceuticals, LLC. A Gibofsky is a stock shareholder of GlaxoSmithKline plc, Bristol-Myers Squibb, Johnson & Johnson, Amgen, Pfizer, and AbbVie. He is a consultant for Iroko Pharmaceuticals, Takeda, Amgen, Abbvie, UCB Inc., Genentech, and Horizon. R Altman is a participant in advisory boards for Iroko Pharmaceuticals; a consultant to Pfizer, Teva Pharmaceutical Industries Ltd., Petah Tikva, Oletec, Novartis, and Johnson & Johnson, and is a consultant and member of the speaker’s bureau for Ferring Pharmaceuticals. S Daniels is an employee of Premier Research Group, which was paid to perform one of these studies. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.