New Data Published in Journal of Opioid Management Show Ameritox’s® Proprietary Medication Monitoring Algorithm Superior to Traditional Urine Testing in Discriminating OxyContin® Drug Regimens

The proprietary algorithm is applied within the company's Rx Guardian pain medication monitoring process, designed to provide physicians with additional information about patients' pain medication use.

January 6, 2010

Baltimore, MD (January 5, 2010) — A study published in the November/December issue of the Journal of Opioid Management revealed that a proprietary algorithm offered by Ameritox®, applied to urine drug levels of OxyContin® C-II (oxycodone HCl controlled-release) Tablets, demonstrated excellent ability to differentiate among three different doses of OxyContin® (oxycodone hydrochloride) compared to a traditional urine drug level test. The proprietary algorithm is applied within the company’s Rx GuardianSM pain medication monitoring process, designed to provide physicians with additional information about patients’ pain medication use.

“These results have important clinical implications in the monitoring of chronic pain patients, highlighting the superior sensitivity of an innovative algorithm to discriminate varying regimens of OxyContin,” said Harry L. Leider, MD, MBA, FACPE, chief medical officer and senior vice president, Ameritox®. “The findings further establish the algorithm as a valuable tool for physicians. When used in combination with other clinical information, Ameritox’s® Rx GuardianSM can help physicians gauge whether patients are taking OxyContin as prescribed. This method provides physicians with the information to make more informed decisions.”

The Rx GuardianSM proprietary algorithm utilizes patient-specific information (including height, weight, urine pH, and urine specific gravity) to normalize the measured drug level and enables physicians to compare the normalized value with expected ranges. Physicians can utilize these personalized test results along with other clinical information, judgment and knowledge of the patient’s history, to make more informed assessments about whether a patient is taking their pain medication in the manner it was prescribed – and further assess the likelihood of drug non-adherence, misuse, or abuse.

Study Results

Rx GuardianSM showed excellent differentiation among three daily regimens of OxyContin® (80mg, 160mg and 240mg per day) compared to traditional urine drug levels, even when conservative adjustments were applied to account for multiple comparisons. Also, application of the algorithm showed less variation between drug levels obtained at two points in time:

  • The concordance correlation coefficient for the standard urine drug (raw) levels, measured by liquid chromatography-mass spectrometry (LC-MS-MS), between days three and four was 0.689 (95% confidence intervals = 0.515, 0.864).
  • The concordance correlation coefficient for the LC-MS-MS values using the Rx GuardianSM methodology was 0.882 (95% confidence intervals = 0.808, 0.956).

Due to greater variability in the raw values, some overlap was observed in the confidence intervals of the various OxyContin® regimens, whereas no overlap was observed in the Rx GuardianSM confidence intervals regardless of the application of a Bonferroni adjustment.

About the Study

The single-group, multi-dose study examined the ability of the Rx GuardianSM algorithm to differentiate among low, medium and high daily doses of OxyContin®. Oxycodone levels were detected in the urine of 36 healthy volunteers using a liquid chromatography-mass spectrometry (LC-MS-MS) assay. Participants were randomized to receive 80mg, 160mg or 240mg of daily OxyContin® to steady state conditions. Urine samples were collected during days three and four. Concordance was tested between pairs of third and fourth day results for both raw and normalized (algorithm-adjusted) LC-MS-MS values for each participant. An analysis of medians was conducted for each of the dosage groupings using Bonett-Price confidence intervals. A Bonferroni adjustment was applied to the confidence intervals to adjust for the multiple comparisons made in the study.

About Ameritox
Ameritox is the nation’s leader in pain medication monitoring solutions, offering specialized laboratory testing and reporting services. Ameritox’s expertise and innovative science provides physicians with insights and support to enhance and optimize the care of chronic pain patients. Ameritox offers Rx GuardianSM, the most thorough and personalized lab service available for monitoring patients on chronic opioid therapy. Medication monitoring helps physicians make more informed clinical decisions and manage the risks and complexities associated with prescribing pain medications. Ameritox is headquartered in Baltimore, MD with laboratory facilities in Midland, TX and Greensboro, NC.

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