Search

Objective: The Centers for Disease Control and Prevention (CDC) recommend that clinicians prescribing opioids for chronic pain should consider at least annual urine drug testing (UDT). We evaluated whether shorter intervals for repeat UDT are associated with decreased rates of drug misuse., Design: Retrospective analysis of deidentified serial UDT and matched prescribing data., Setting: We analyzed Quest Diagnostics 2016-2017 UDT results from new patients being monitored for prescription drug adherence, in nonsubstance use disorder (SUD) treatment environments., Main Outcome Measures: Drug misuse was defined as the absence of a prescribed substance or the presence of a nonprescribed substance. Patients with ≥3 sets of the UDT results were included., Results: UDT results from 49,601 patients (148,803 specimens) were tested. Declines in misuse between the first and second UDT were highest for those tested at the shortest intervals: approximately weekly, 19 percent; monthly, 15 percent; bimonthly, 12 percent; quarterly, 9 percent; semiannually, 3 percent; misuse rates increased by 1 percent for patients tested annually. Declines in misuse were more pronounced for opioids than other drug groups. Substantial declines in positivity were noted for heroin (32 percent) and nonprescribed fentanyl (10 percent). Declines in misuse between the second and third UDT followed a similar pattern., Conclusions: UDT intervals of ≤ quarterly were associated with marked declines, but testing annually or semiannually was not associated with consistent decreases. Our findings suggest that clinical strategies that include serial testing conducted quarterly or sooner may be instrumental in decreasing drug misuse. Testing more frequently than "at least once annually" should be considered by clinicians monitoring potential drug misuse.

Opioids can be an effective treatment option for appropriate patients with chronic pain for whom nonpharmacological or nonopioid treatment does not provide adequate pain relief. However, extended-release (ER) opioid formulations, because of their high drug content, are attractive options for nonmedical use and abuse. Xtampza ® ER (oxycodone DETERx ® ) capsules, an ER abuse-deterrent formulation (ADF), contain microspheres that combine oxycodone with inactive ingredients to increase the difficulty of tampering with the ER mechanism. The aim of this article is to review five previously published studies highlighting the impact of physical manipula-tion (ie, crushing and chewing) on the pharmacokinetic (PK) properties of orally administered Xtampza ER compared with immedi-ate-release (IR) oxycodone and/or reformulated OxyContin ® (the first approved oxycodone ER ADF). Across five studies, manipulated (crushed or chewed) Xtampza ER retained an ER PK profile similar to that of intact Xtampza ER, with respect to maximum plasma con-centration (Cmax) and time to Cmax. Additionally, bioequivalence was established between manipulated and intact Xtampza ER, based on Cmax and area under the concentration-time curve values in healthy volunteers and nondependent recreational opioid users. In contrast, crushed OxyContin failed to retain the ER PK profile of intact OxyContin and was bioequivalent to IR oxycodone, based on Cmax in healthy volunteers. The retention of ER PK properties when capsule contents are physically manipulated before oral administra-tion suggests Xtampza ER has lower potential to be manipulated for oral abuse when compared with IR oxycodone or OxyContin.

Objective: Efficacy and safety of naloxegol, a peripherally acting µ-opioid receptor antagonist that significantly reduces opioid-induced constipation (OIC), were assessed for patient subgroups defined post hoc by baseline maintenance opioid characteristics., Design: Post hoc, pooled analysis of data from two 12-week, randomized, double-blind, placebo-controlled, phase 3 studies., Setting: Two hundred fifty-seven outpatient centers in the United States and Europe., Patients: Patients with noncancer pain and OIC., Interventions: Naloxegol (12.5 or 25 mg daily) or placebo., Main Outcomes Measures: The primary efficacy endpoint was the proportion of patients meeting response criteria at 12 weeks: at least three spontaneous bowel movements (SBMs)/wk and an increase from baseline of at least one SBM for ≥9 of 12 weeks and ≥3 of the last 4 weeks. No adjustments were made for multiplicity; all p values are descriptive., Results: This analysis included 1,337 patients. Increases in the proportion of patients who achieved response at 12 weeks were observed with naloxegol 25 mg versus placebo in patients taking maintenance oxycodone, hydrocodone, morphine, or fentanyl (p ≤ 0.038); patients taking either ≥120 or <120 morphine-equivalent units at baseline (p ≤ 0.032); and patients treated with their current opioid for >6 months (p ≤ 0.035). Efficacy results were less robust with naloxegol 12.5 mg versus placebo. Adverse event incidences were generally comparable across treatment groups, regardless of opioid dose or duration of therapy but were numerically higher with some specific baseline opioids., Conclusion: In this post hoc, exploratory analysis, naloxegol 25 mg showed similar efficacy in treating OIC regardless of maintenance opioid type, dose, or duration of opioid use at baseline.

Background: The introduction of newly formulated extended release (ER) morphine with sequestered naltrexone (Embeda) has provided another treatment option for moderate to severe persistent pain. Embeda was designed to be an abuse-deterrent opioid formulation. Naltrexone is a centrally acting opioid receptor antagonist that blocks the action of opioid. When taken as directed, insignificant amount of sequestered naltrexone would reach systemic circulation, but upon tampering, the released naltrexone may blunt the euphoria of opioids, and possibly precipitate opioid withdrawal in opioid-dependent patient., Objective: To describe a case report ofa 50-year-old opioid-dependent male who developed acute opioid withdrawal after taking crushed Embeda., Case Report: A 50-year-old male with severe, chronic low back pain due to degenerative disc disease was referred to our clinic for pain management. He was taking ER oxycodone 80 mg tid and Roxicodone 30 mg qid prn, with inadequate pain relief A trial of ER oxymorphone was decided, at 40 mg 1-2 doses bid. The patient returned to the clinic 1 week early, out of his ER oxymorphone. At this time, the decision to switch him to Embeda was made, at 80 mg/3.2 mg, 1-2 doses bid. The patient and his family members were counseled about risk involved with tampering with Embeda. A few hours later, our clinic was informed that the patient was brought to emergency room by ambulance, in severe opioid withdrawal. He was treated with IV fluid, antiemetics, clonidine, and IV hydromorphone. His condition improved and he was discharged home the next morning. Later on, the patient admitted that he took two prescribed Embeda within half an hour, the 1st one whole and the 2nd one crushed. He further admitted that he did so against our medical advice. CONCLUSION. Taking tampered Embeda may precipitate opioid withdrawal in opioid-tolerant patient. To the best of our knowledge, this is the first report of induced opioid withdrawal following consumption of crushed Embeda.