Injectable

Population pharmacokinetics of extended-release injectable naltrexone (XR-NTX) in patients with alcohol dependence *.(Report): An article from: Journal of Studies on Alcohol and Drugs Review

Population pharmacokinetics of extended-release injectable naltrexone (XR-NTX) in patients with alcohol dependence *.(Report): An article from: Journal of Studies on Alcohol and Drugs Overview

This digital document is an article from Journal of Studies on Alcohol and Drugs, published by Thomson Gale on November 1, 2007. The length of the article is 5312 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.

From the author: Objective: Injectable extended-release naltrexone (XRNTX; Vivitrol) has recently been approved for the treatment of alcohol dependence. A population pharmacokinetic (PPK) analysis examined the possibility of altered pharmacokinetics for naltrexone and its primary metabolite, 6[beta]-naltrexol, in subpopulations with a potential for alcohol-dependence treatment. Method: Data from four clinical studies of XRNTX were pooled. Absorption was modeled as a sequential release in three phases. The pharmacokinetics of naltrexone and 6[beta]-naltrexol were modeled as one-compartment disposition submodels, parameterized in terms of clearance (CL) and volume of distribution (V). The impact of age, weight, gender, race, hepatic function, renal function, smoking, and alcohol/opioid dependence on PPK parameter estimates was analyzed. Results: Plasma concentrations were available from 453 subjects. More than half of the subjects (59%) were alcohol dependent, and 27% were dependent on both alcohol and opioids. Naltrexone CL (140 L/h) and V (38,300 L) were dependent on weight (changes of 0.548 L/h/kg and 0.655 L/kg, respectively) and were 23% and 35% higher, respectively, in subjects with alcohol and/or opioid dependence than in healthy subjects. Naltrexone CL also was dependent on age (-0.108 L/h/year); 6[beta]naltrexol CL (65.1 L/h) was dependent on creatinine CL (0.229 L/h/ml/ minute) and alkaline phosphatase (-0.130 L/h/IU/L), and was increased by 18% in smokers and in alcohol- and/or opioid-dependent subjects. Conclusions: Although statistically significant covariate-parameter relationships were identified, they were not considered clinically meaningful, suggesting that dosing adjustments of XR-NTX based on weight, age, gender, health status, smoking status, creatinine CL, and hepatic function differences should not be necessary.

Citation Details
Title: Population pharmacokinetics of extended-release injectable naltrexone (XR-NTX) in patients with alcohol dependence *.(Report)
Author: Joi L. Dunbar
Publication:Journal of Studies on Alcohol and Drugs (Magazine/Journal)
Date: November 1, 2007
Publisher: Thomson Gale
Volume: 68 Issue: 6 Page: 862(9)

Article Type: Report

Distributed by Thomson Gale

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