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

Authors

  • 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

DOI:

https://doi.org/10.5055/jom.2012.0131

Keywords:

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

Abstract

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.

Author Biographies

Kerri A. Schoedel, PhD

INC Research (formerly Kendle Early Stage), Toronto, Ontario, Canada

Robert L. Rolleri, PharmD

Pfizer Inc, 4000 Centre Green Way, Suite 260, Cary, North Carolina

Janice Y. Faulknor, MD, CCFP

INC Research (formerly Kendle Early Stage), Toronto, Ontario, Canada

Glenn C. Pixton, MS

Pfizer Inc, 4000 Centre Green Way, Suite 260, Cary, North Carolina

Nancy Chen, PhD

INC Research (formerly Kendle Early Stage), Toronto, Ontario, Canada

Almasa Bass, PharmD

Pfizer Inc, 4000 Centre Green Way, Suite 260, Cary, North Carolina

Kenneth W. Sommerville, MD

Pfizer Inc, 4000 Centre Green Way, Suite 260, Cary, North Carolina

Edward Sellers, MD, PhD, FRCPC, FACP

Kendle Early Stage, Toronto, Ontario, Canada; DL Global Partners Inc., Toronto, Canada. Professor, University of Toronto, Canada

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Published

09/01/2012

How to Cite

Schoedel, PhD, K. A., R. L. Rolleri, PharmD, J. Y. Faulknor, MD, CCFP, G. C. Pixton, MS, N. Chen, PhD, A. Bass, PharmD, K. W. Sommerville, MD, and E. Sellers, MD, PhD, FRCPC, FACP. “Assessing Subjective and Physiologic Effects Following Intranasal Administration of a New Formulation of Immediate Release Oxycodone HCl (Oxecta™) Tablets in Nondependent Recreational Opioid Users”. Journal of Opioid Management, vol. 8, no. 5, Sept. 2012, pp. 315-27, doi:10.5055/jom.2012.0131.