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Title of Journal: Pharm Res

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Abbravation: Pharmaceutical Research

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Springer US

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DOI

10.1016/0040-8166(80)90020-8

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1573-904X

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Pharmacokinetic and Pharmacodynamic Modeling of Op

Authors: Xu Steven Xu Mila Etropolski David Upmalis Akiko Okamoto Rachel Lin Partha Nandy
Publish Date: 2012/05/23
Volume: 29, Issue: 9, Pages: 2555-2564
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Abstract

The analysis was based on a study in patients with moderatetosevere pain following bunionectomy Population PK modeling was conducted to estimate population PK parameters for tapentadol oxycodone and oxymorphone Time to AEs was analyzed using Cox proportionalhazards modelsRisk of nausea vomiting and constipation significantly increased with exposure to tapentadol or oxycodone/oxymorphone However elevated risk per drug exposure of AEs for tapentadol was ~3–4 times lower than that of oxycodone while elevated AE risk per drug exposure of oxycodone was ~60 times lower than that for oxymorphone consistent with reported in vitro receptor binding affinities for these compounds Simulations show that AE incidence following administration of tapentadol IR is lower than that following oxycodone IR intake within the investigated range of analgesic noninferiority dose ratiosAll authors are employees of Janssen Research and Development The analyses and studies described in this report were funded by Janssen Research and Development Steven Xu is an adjunct assistant professor in the School of Public Health at the University of Medicine and Dentistry of New Jersey

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