Innovations In Clinical Neuroscience

Hot Topics in Pain Management October 2017

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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JOURNAL WATCH Hot Topics in Pain Management [October 2017] 18 doi:10.1093/pm/pnw213. Summary. To examine the ability of a new extended-release formulation of morphine (Morphine ARER) to retain extended-release characteristics even when crushed and delivered intranasally, researchers conducted a randomized, double-blind, double-dummy, placebo- controlled, four-way crossover study (n=25) to compare the new formulation to commercially available crushed intranasal extended-release morphine sulfate. They found equivalent max high scores for crushed vs intact delivery of the new formulation, but a lower max high when the new formulation was compared to the commercially available formulation. They also observed lower mean scores for good drug effects, drug high, overall drug liking, and desire to re-use for the new formulation compared to the commercially available formulation. Authors conclude that, compared to commercially available extended-release morphine sulfate, the new morphine formulation has lower potential for abuse through intranasal delivery. * PMID 27651506 Relative bioavailability, intranasal abuse potential, and safety of benzhydrocodone/acetaminophen compared with hydrocodone bitartrate/ acetaminophen in recreational drug abusers. Guenther SM, Mickle TC, Barrett AC, et al. Pain Med 2017 Aug 25. doi: 10.1093/pm/ pnx195. [Epub ahead of print] Summary. Researchers used a single- center, randomized, double-blind, double-dummy, two-part study (dose selection followed by main phase) design to compare bioavailability and intranasal abuse potential of two immediate-release hydrocodone- acetaminophen combination analgesics – benzhydrocodone vs commercially available hydrocodone bitartrate – in 42 healthy adult, nondependent, recreational opioid users with a history of intranasal abuse. They found lower maximum serum concentrations, reduced early cumulative hydrocodone exposures, and lower drug liking scores for benzhydrocodone compared to hydrocodone bitartrate, although peak drug liking scores were not different. Authors conclude that the combination of features in benzhydrocodone should deter abuse via intranasal delivery. * PMID 29025138 See also: Evaluation of the relative intranasal abuse potential of a hydrocodone extended-release tablet formulated with abuse-deterrence technology in nondependent, recreational opioid users. Bond M, Schoedel KA, Rabinovich-Guilatt L, et al. Pain Med 2017 Jun 14. doi:10.1093/pm/pnx133. [Epub ahead of print] PMID: 29016880. Effect of food on the pharmacokinetics of single- and multiple-dose hydrocodone extended release in healthy subjects. Bond M, Rabinovich-Guilatt L, Selim S, et al. Clin Drug Investig 2017 Sep 25. doi:10.1007/s40261-017-0575-3. [Epub ahead of print] Summary. Authors report outcomes from two randomized, open-label, crossover studies examining the effect of food on oral bioavailability of single-dose (n=35 completing out of 40) and multi-dose (n=30 completing out of 43) extended- release hydrocodone in healthy subjects receiving naltrexone to minimize opioid- related adverse events. They found that maximum serum concentrations increased equivalently in fed and fasted individuals after a single dose, but little to no effect of food on serum concentration for multi-dose delivery over multiple days. Authors conclude that the extended- release hydrocodone formulation studied here may be administered with or without food. * PMID 28948482. Real-world utilization of once-daily extended-release abuse deterrent formulation of hydrocodone: a comparison with the pre-approval randomized clinical trials. Taber L, Bond TC, Wang X, et al. J Pain Res 2017 Jul 25;10:1741-1746. doi: 10.2147/JPR.S140990. eCollection 2017. Summary. Researchers used two previously published studies (Wen et al. 2015a, 2015b) on once-daily hydrocodone tablets formulated with abuse-deterrent properties to retrospectively compare dosing and use patterns observed in the trials to real- world data collected 12 to 14 months post approval in the U.S. Here, real world data are defined as "observations of effects based on what happens after a prescriptive treatment decision is made where the researcher cannot control who gets what treatment and cannot control the medical management of the patient beyond observing the outcomes." They found daily doses averaging 60mg, reduced need for rescue medication (thus lower total opioid dose over time), average time on drug < 80 days, and average daily consumption of 1.04 pills per day. Authors conclude that approximately a year after approval, actual use of the formulation is in keeping with originally approved uses. • Wen W, Sitar S, Lynch SY, et al. 2015a. A multicenter, randomized, double- blind, placebo-controlled trial to assess the efficacy and safety of single-entity, once-daily hydrocodone tablets in patients with uncontrolled moderate to severe chronic low back pain. Expert Opin Pharmacother 16(11):1593-606. doi: 10.1517/14656566.2015.1060221. Epub 2015 Jun 26. PMID: 26111544. • Wen W, Taber L, Lynch SY, et al. 2015b. 12-Month safety and effectiveness of once-daily hydrocodone tablets formulated with abuse-deterrent properties in patients with moderate to severe chronic pain. J Opioid Manag 11(4):339-56. doi: 10.5055/ jom.2015.0283. PMID: 26312961. * PMID 28794653 JOURNAL WATCH

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