Ikuko Yataba1, Noboru Otsuka1, Isao Matsushita1, Hideo Matsumoto2, Yuichi Hoshino3. 1. a Development Headquarters, Taisho Pharmaceutical Co., Ltd. , Tokyo , Japan. 2. b Institute for Integrated Sports Medicine, School of Medicine, Keio University , Tokyo , Japan , and. 3. c Orthopedics Surgery, School of Medicine, Jichi Medical University , Tochigi , Japan.
Abstract
OBJECTIVES: S-flurbiprofen plaster (SFPP) is a novel non-steroidal anti-inflammatory drug (NSAID) patch, intended for topical treatment for musculoskeletal diseases. This trial was conducted to examine the effectiveness of SFPP using active comparator, flurbiprofen (FP) patch, on knee osteoarthritis (OA) symptoms. METHODS: This was a phase III, multi-center, randomized, adequate, and well-controlled trial, both investigators and patients were blinded to the assigned treatment. Enrolled 633 knee OA patients were treated with either SFPP or FP patch for two weeks. The primary endpoint was improvement in knee pain on rising from the chair as assessed by visual analogue scale (rVAS). Safety was evaluated through adverse events (AEs). RESULTS: The change in rVAS was 40.9 mm in SFPP group and 30.6 mm in FP patch group (p < 0.001). The incidence of drug-related AEs at the application site was 9.5% (32 AEs, 29 mild and 3 moderate) in SFPP and 1.6% in FP patch (p < 0.001). Withdrawals due to AE were five in SFPP and one in FP patch. CONCLUSIONS: The superiority of SFPP in efficacy was demonstrated. Most of AEs were mild and few AEs led to treatment discontinuation. Therefore, SFPP provides an additional option for knee OA therapy.
OBJECTIVES: S-flurbiprofen plaster (SFPP) is a novel non-steroidal anti-inflammatory drug (NSAID) patch, intended for topical treatment for musculoskeletal diseases. This trial was conducted to examine the effectiveness of SFPP using active comparator, flurbiprofen (FP) patch, on knee osteoarthritis (OA) symptoms. METHODS: This was a phase III, multi-center, randomized, adequate, and well-controlled trial, both investigators and patients were blinded to the assigned treatment. Enrolled 633 knee OA patients were treated with either SFPP or FP patch for two weeks. The primary endpoint was improvement in knee pain on rising from the chair as assessed by visual analogue scale (rVAS). Safety was evaluated through adverse events (AEs). RESULTS: The change in rVAS was 40.9 mm in SFPP group and 30.6 mm in FP patch group (p < 0.001). The incidence of drug-related AEs at the application site was 9.5% (32 AEs, 29 mild and 3 moderate) in SFPP and 1.6% in FP patch (p < 0.001). Withdrawals due to AE were five in SFPP and one in FP patch. CONCLUSIONS: The superiority of SFPP in efficacy was demonstrated. Most of AEs were mild and few AEs led to treatment discontinuation. Therefore, SFPP provides an additional option for knee OA therapy.
Entities:
Keywords:
Adequate and well-controlled trial; NSAIDs; Osteoarthritis; Pain; S-flurbiprofen
Authors: Corey W Hunter; Timothy R Deer; Mark R Jones; George C Chang Chien; Ryan S D'Souza; Timothy Davis; Erica R Eldon; Michael F Esposito; Johnathan H Goree; Lissa Hewan-Lowe; Jillian A Maloney; Anthony J Mazzola; John S Michels; Annie Layno-Moses; Shachi Patel; Jeanmarie Tari; Jacqueline S Weisbein; Krista A Goulding; Anikar Chhabra; Jeffrey Hassebrock; Chris Wie; Douglas Beall; Dawood Sayed; Natalie Strand Journal: J Pain Res Date: 2022-09-08 Impact factor: 2.832