Open Access Open Access  Restricted Access Subscription or Fee Access

Assessing subjective and physiologic effects following intranasal administration of a new formulation of immediate release oxycodone HCl (Oxecta™) tablets in nondependent recreational opioid users

Kerri A. Schoedel, PhD, Robert L. Rolleri, PharmD, Janice Y. Faulknor, MD, CCFP, Glenn C. Pixton, MS, Nancy Chen, PhD, Almasa Bass, PharmD, Kenneth W. Sommerville, MD, Edward Sellers, MD, PhD, FRCPC, FACP


Objective: To evaluate the pharmacodynamic effects (subjective and physiologic) of a new formulation of immediate release oxycodone HCl (IRO-A; Oxecta) tablets compared with immediate release oxycodone HCl (IRO; Roxicodone®) tablets when crushed and administered intranasally to nondependent recreational opioid users.

Design: Single-center, single-dose, randomized, double-blind, active-controlled two-way crossover study.

Setting: Inpatient Clinical Pharmacology Unit, Toronto, Canada.

Participants: Nondependent, recreational opioid users aged 18-55 years.

Interventions: Subjects able to discriminate intranasally administered crushed IRO from placebo were randomized to receive 15 mg crushed IRO-A and crushed IRO in crossover fashion in treatment phase.

Main outcome measures: Primary subjective endpoints were maximum effect (Emax) for Drug Liking and effect at 8 hours (E8h) postdose for Take Drug Again and Overall Drug Liking. All were assessed using bipolar 0-100 visual analog scale (VAS; 50 points = neutral). Secondary pharmacodynamic endpoints included other VAS endpoints, pupillometry, and subject-rated scales for nasal effects.

Results: Forty subjects were randomized to treatment; 39 were evaluable, one subject was excluded for postdose vomiting. Subjects were mostly male (80 percent) and White (75 percent). Least squares mean Drug Liking VAS Emax (70.8 vs 93.5), Overall Drug Liking E8h (47.8 vs 87.4), and Take Drug Again E8h (45.9 vs 91.3) were significantly lower for crushed IRO-A vs IRO (all p < 0.0001). A significant sequence effect was found, but lower liking of IRO-A was observed for both treatment sequence groups. Pupillary responses between treatments were similar overall, but differences were noted for some endpoints/time points. Adverse events common to opioids were observed with both treatments. Subjects experienced more nasal-related symptoms with IRO-A.

Conclusions: Crushed IRO-A tablets demonstrated lower scores on “drug liking,” “overall drug liking,” and “take drug again” than crushed IRO when administered intranasally to nondependent recreational opioid users.


opioid, oxycodone, intranasal, abuse potential, Drug Liking, misuse

Full Text:



Kuehn BM: Opioid prescriptions soar: Increase in legitimate use as well as abuse. JAMA. 2007; 297(3): 249-251.

Manchikanti L: National drug control policy and prescription drug abuse: Facts and fallacies. Pain Physician. 2007; 10(3): 399-424.

Birnbaum HG, White AG, Reynolds JL, et al.: Estimated costs of prescription opioid analgesic abuse in the United States in 2001: A societal perspective. Clin J Pain. 2006; 22(8): 667-676.

US Department of Health and Human Services, Centers for Disease Control and Prevention: Emergency department visits involving nonmedical use of selected prescription drugs-United States, 2004-2008. MMWR Morb Mortal Wkly Rep. 2010; 59(23): 705-714.

Warner M, Chen LH, Makuc DM: Increase in fatal poisonings involving opioid analgesics in the United States, 1999-2006. In National Center for Health Statistics (NCHS) Data Brief. Hyattsville, MD: National Center for Health Statistics, 2009.

Dart R: RADARS System Report: RADARS System Analysis of Data on Immediate Release Opioids Vs. Long Acting Opioids for King Pharmaceuticals, 2010.

Mccabe SE, Cranford JA, Boyd CJ, et al.: Motives, diversion and routes of administration associated with nonmedical use of prescription opioids. Addict Behav. 2007; 32(3): 562-575.

Butler SF, Fernandez KC, Chang A, et al.: Measuring attractiveness for abuse of prescription opioids. Pain Med. 2010; 11(1): 67-80.

Hays L, Kirsh KL, Passik SD: Seeking drug treatment for oxycontin abuse: A chart review of consecutive admissions to a substance abuse treatment facility in Kentucky. J Natl Compr Canc Netw. 2003; 1(3): 423-428.

Young AM, Havens JR, Leukefeld CG: Route of administration for illicit prescription opioids: A comparison of rural and urban drug users. Harm Reduct J. 2010; 7: 24.

Butler SF, Budman SH, Licari A, et al.: National addictions vigilance intervention and prevention program (NAVIPPROTM): A real-time, product-specific, public health surveillance system for monitoring prescription drug abuse. Pharmacol Drug Saf. 2008; 17(12): 1142-1154.

Katz N, Dart RC, Bailey E, et al.: Tampering with prescription opioids: Nature and extent of the problem, health consequences, and solutions. Am J Drug Alcohol Abuse. 2011; 37(4): 205-217.

Oxecta [Package Insert]. Bristol, TN: Pfizer Inc, June 2011.

American Psychiatric Association: Substance-related disorders. In Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR. 4th ed., text revision. Washington, DC: American Psychiatric Association, 2000: 191.

Wesson DR, Ling W: The clinical opiate withdrawal scale (COWS). J Psychoactive Drugs. 2003; 35(2): 253-259.

Roxicodone [Package Insert]. Newport, KY: Xanodyne Pharmaceuticals, Inc., 2009.

US Department of Health and Human Services, Food and Drug Administration: Guidance for Industry Assessment of Abuse Potential of Drugs. Silver Spring, MD: Center for Drug Evaluation and Research, 2010. Available at http://www.Fda.Gov/Downloads/Drugs/Guidancecomplianceregulatoryinformation/Guidances/UCM198650.Pdf. Accessed August 28, 2012.

Griffiths RR, Bigelow GE, Ator NA: Principles of initial experimental drug abuse liability assessment in humans. Drug Alcohol Depend. 2003; 70(3 Suppl): S41-S54.

Shram MJ, Schoedel KA, Setnik B, et al.: The relationship between objective and subjective effects measures used in abuse liability testing: An exploratory analysis using opioid agonists. Poster Presented at 73rd Annual Meeting of the College on Problems of Drug Dependence, Hollywood, FL, June 18-23, 2011.



  • There are currently no refbacks.