The efficacy and safety of S-flurbiprofen plaster in the treatment of knee osteoarthritis

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SCIENCE
The efficacy and safety of S-flurbiprofen plaster in the treatment of knee osteoarthritis
Key Take-Away: 

S-flurbiprofen plaster (SFPP) formulation allows sufficient deep-tissue penetration of S-flurbiprofen. Use of SFPP is observed as a remarkable pain reliever in the knee osteoarthritis (OA) patients.

SFPP is an innovative non-steroidal anti-inflammatory drug (NSAID) patch with an active ingredient S-flurbiprofen, intended for the topical treatment of OA.

ABSTRACT: 
Background: 

SFPP is an innovative non-steroidal anti-inflammatory drug (NSAID) patch with an active ingredient S-flurbiprofen, intended for the topical treatment of OA.

NSAID patches are convenient to use and show much less gastrointestinal side effects than oral NSAIDs. However, its percutaneous absorption is not sufficient for the expression of clinical efficacy at a satisfactory level. SFPP has shown dramatic improvement in percutaneous absorption results from animal and clinical studies. In the present study, the efficacy and safety of SFPP were compared with placebo in patients with knee OA to determine its optimal dose. This was a multicenter, randomized, double-blind, parallel-group comparative study.

Methods: 

Enrolled 509 knee OA patients were treated with placebo or SFPP at 10, 20, or 40 mg was applied on the affected site once daily for 2 weeks.

The primary endpoint for efficacy was the improvement in knee pain on rising from the chair assessed by visual analog scale (VAS). The other endpoints were clinical symptoms, pain on walking, and global assessment by both investigator and the patient reported. Safety was evaluated by observing adverse events (AEs).

Results: 

VAS change in knee pain from baseline to trial end was reported to be dose-dependent, least squares mean was 29.5, 31.5, 32.0, and 35.6 mm in the placebo and SFPP 10, 20, and 40 mg, respectively.

A significant difference was observed between placebo and SFPP 40 mg (p=0.001). In contrast, the effect of SFPP at a dose ≤20 mg was not significantly different from that of placebo. The proportion of the patients who achieved 50% pain relief was 72.4% in 40 mg and 51.2% in placebo (p<0.001). In all other endpoints, SFPP 40 mg showed significant improvement compared with placebo. The incidence of AEs was not different across all four groups, and no severe AEs were observed.

Conclusion: 

Clinically relevant pain relief was observed in all groups including placebo. Especially 40 mg showed remarkable pain relief, not the only primary endpoint but also all the other endpoints with significant differences over placebo.

The safety profile of SFPP 40 mg was not different from that of placebo. Therefore, 40 mg was determined as the optimal tested dose.

Source:

Journal of Pain Research

Link to the source:

https://www.dovepress.com/the-efficacy-and-safety-of-s-flurbiprofen-plaster-in-the-treatment-of--peer-reviewed-fulltext-article-JPR

The original title of the article:

The efficacy and safety of S-flurbiprofen plaster in the treatment of knee osteoarthritis: A phase II, randomized, double-blind, placebo-controlled, dose-finding study.

Author:

Ikuko et al.

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