Transdermal fentanyl matrix patches Matrifen® and Durogesic® DTrans® are bioequivalent

Abstract

Aim The pharmacokinetic profiles of the two commercially available transdermal fentanyl patches Matrifen® (100 μg/h) and Durogesic® DTrans® (100 μg/h), used to manage severe chronic pain, were compared regarding their systemic exposure, rate of absorption, and safety. Methods Transdermal matrix fentanyl patches [Matrifen® or Durogesic® DTrans® (100 μg/h)] were applied for 72 h to 30 healthy male subjects in a randomized, four-period (two replicated treatment sequences), crossover study; 28 subjects completed the study. The pharmacokinetic parameters of fentanyl were determined for 144 h after application using plasma samples. Safety of the patches (adverse events) and performance (adhesion, skin irritation, residual fentanyl content in the patch) were evaluated. Results The plasma concentration–time curves of Matrifen® (Test) and Durogesic® DTrans® (Reference) were similar. The geometric least square means of the Test/Reference ratio (90% confidence intervals [CI]) were within the range of 80–125%, demonstrating bioequivalence of Matrifen® and Durogesic® DTrans®: AUC 0-tlast 92.5 (CI 88.7–96.4), AUC 0-inf 91.7 (CI 88.0–95.7), and C max 98.3 (CI 92.9–104.1). After 72 h application, Matrifen® had a more efficient utilization of fentanyl (mean ± SD 82.3 ± 9.43%) than Durogesic® DTrans® (52.3 ± 12.8%), with substantially lower residual fentanyl in patch after use. The pharmacokinetic parameters showed lower intra- and inter-subject variability for Matrifen® than for Durogesic® DTrans® patch. Conclusions Despite different technologies, the transdermal fentanyl patches Matrifen® and Durogesic® DTrans® are bioequivalent. Compared with Durogesic® DTrans®, the Matrifen® patch had lower initial and lower residual fentanyl content, as well as lower intra- and inter-subject variability, allowing reproducible drug delivery and reliable analgesia.