Bioequivalence and safety of a novel fentanyl transdermal matrix system compared with a transdermal reservoir system

Authors

  • Kenneth Todd Moore, MS
  • Holly D. Adams, MS
  • Jaya Natarajan, PhD
  • Jay Ariyawansa, MS
  • Henry M. Richards, MD

DOI:

https://doi.org/10.5055/jom.2011.0052

Keywords:

fentanyl, matrix, transdermal, pharmacokinetics, drug delivery

Abstract

Objectives: Fentanyl is a potent synthetic opioid used for the management of chronic pain. A newer transdermal matrix system was developed and compared with a reservoir system used in the United States.
Setting: An open-label, single-center, randomized, two-period crossover study was conducted to evaluate the bioequivalence of the transdermal matrix system to the transdermal reservoir system. Seventy-four subjects completed treatment with both the reservoir system (100 μg/h) and the matrix system (100 μg/h), each applied for 72 hours. After application of the first system, subjects completed a 9-day washout and then crossed over to receive the other system for another 72 hours.
Main outcome measure: Blood samples for the determination of serum fentanyl concentrations were taken in each treatment period for up to 120 hours following application.
Results: The ratios of geometric means for maximum fentanyl concentration (Cmax) and area under the concentration-time curve (AUClast and AUC∞ ) were 106 percent, 110 percent, and 110 percent, respectively. The 90% confidence intervals for the ratios of the geometric means were contained within the bioequivalence criteria of 80-125 percent. The matrix system adhered well to skin. Systemic and topical safety profiles were comparable between treatments.
Conclusions: The transdermal fentanyl matrix system adhered well, was well tolerated, and produced systemic exposures of fentanyl that were bioequivalent to the reservoir system.

Author Biographies

Kenneth Todd Moore, MS

Johnson & Johnson Pharmaceutical Research & Development, LLC, Titusville, New Jersey.

Holly D. Adams, MS

Johnson & Johnson Pharmaceutical Research & Development, LLC, Titusville, New Jersey.

Jaya Natarajan, PhD

Johnson & Johnson Pharmaceutical Research & Development, LLC, Raritan, New Jersey.

Jay Ariyawansa, MS

Johnson & Johnson Pharmaceutical Research & Development, LLC, Raritan, New Jersey.

Henry M. Richards, MD

Johnson & Johnson Pharmaceutical Research & Development, LLC, Titusville, New Jersey.

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Published

01/15/2018

How to Cite

Moore, MS, K. T., H. D. Adams, MS, J. Natarajan, PhD, J. Ariyawansa, MS, and H. M. Richards, MD. “Bioequivalence and Safety of a Novel Fentanyl Transdermal Matrix System Compared With a Transdermal Reservoir System”. Journal of Opioid Management, vol. 7, no. 2, Jan. 2018, pp. 99-107, doi:10.5055/jom.2011.0052.

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