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

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 microg/h) and the matrix system (100 microg/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 AUCinfinity) 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.

• Authors: Kenneth Todd Moore, Holly D Adams, Jaya Natarajan, Jay Ariyawansa, Henry M Richards
• Journal: Journal of opioid management (J Opioid Manag) 2011 Mar-Apr Vol. 7 Issue 2 Pg. 99-107 ISSN: 1551-7489 [Print] United States
• PMID: 21561033 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Analgesics, Opioid
• Fentanyl

Topics

• Administration, Cutaneous
• Adolescent
• Adult
• Analgesics, Opioid (administration & dosage)
• Cross-Over Studies
• Female
• Fentanyl (administration & dosage, adverse effects, pharmacokinetics)
• Humans
• Male
• Middle Aged
• Therapeutic Equivalency