Efficacy of epicutaneous Diractin® (ketoprofen in Transfersome® gel) for the treatment of pain related to eccentric muscle contractions
Matthias Rother1,2, Egbert J Seidel3, Priscilla M Clarkson4, Stefan Mazgareanu1, Ulrich Vierl1, ilka Rother2
1IDEA AG, Muenchen, Germany; 2X-pert Med GmbH, Graefelfing, Germany; 3Department Physical and Rehabilitation Medicine, Sophien- and Hufeland-Clinic Centre, Weimar, Germany; 4Department of Kinesiology, School of Public Health and Health Sciences, University of Massachusetts, Amherst, MA, USA
Objective: To investigate the effect of epicutaneously applied Diractin® (ketoprofen in Transfersome® gel) on pain induced by eccentric muscle contractions.
Methods: Three pilot studies which were subsequently pooled for a meta-analysis compared the efficacy of a single application of 25 mg ketoprofen in Diractin® to 25 mg oral ketoprofen and placebo for the treatment of pain induced by 50 eccentric contractions of the elbow flexor muscles. In addition, the effect of multiple usage of up to 100 mg ketoprofen in Diractin® bid over seven days on pain induced by walking down stairs with a total altitude of 200 meters was investigated.
Results: A single dose of 25 mg ketoprofen in Diractin® after the elbow flexion exercise was significantly superior to placebo from 5 to 12 hours after treatment and also to oral ketoprofen at some time points after treatment. In contrast, oral ketoprofen was not different to placebo at any time after treatment. Multiple doses of up to 100 mg ketoprofen Diractin® provided significant more pain relief than placebo on muscle pain induced by walking down stairs.
Conclusions: Eccentric exercise-induced muscle soreness was shown to be an appropriate acute pain model to evaluate the efficacy of nonsteroidal anti-inflammatory drugs applied epicutaneously with Transfersome® carriers. Diractin® proved to be efficacious in relieving pain from eccentric muscle contractions and muscle overexercise, respectively. The effect needs to be confirmed in a larger prospective clinical trial.
Keywords: ketoprofen, Transfersome®, epicutaneous application, eccentric muscle contraction, delayed onset muscle soreness