Patient-reported health-related quality of life, work productivity, and activity impairment during treatment with ALO-02 (extended-release oxycodone and sequestered naltrexone) for moderate-to-severe chronic low back pain

Arnold J Weil, Elizabeth T Masters, Alexandra I Barsdorf, Almasa Bass, Glenn Pixton, Jacquelyn G Wilson, Gernot Wolfram, Arnold J Weil, Elizabeth T Masters, Alexandra I Barsdorf, Almasa Bass, Glenn Pixton, Jacquelyn G Wilson, Gernot Wolfram

Abstract

Background: The efficacy of ALO-02, an abuse-deterrent formulation containing extended-release oxycodone and sequestered naltrexone, in the treatment of chronic low back pain (CLBP) was studied in a 12-week randomized controlled trial. Primary efficacy endpoint results have been published previously (Rauck et al., 2015). The current paper focuses on patient-reported outcomes for health-related quality of life (HRQL), work productivity, and activity impairment that were assessed during this study.

Methods: This was a double-blind, placebo-controlled, randomized withdrawal study in patients with moderate-to-severe CLBP. After a screening period (≤2 weeks), patients entered an open-label titration period (4-6 weeks). Treatment responders were then randomized to a double-blind placebo-controlled treatment period (12 weeks). HRQL was assessed using changes in the Short Form-36 v2 Health Survey (SF-36v2) and the EuroQol-5 Dimensions Health Questionnaire 3-Level version (EQ-5D-3L). Work productivity and regular activities were evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP).

Results: A total of 410 patients received ALO-02 during the open-label titration period, of which 280 (intent-to-treat (ITT) population) were treated during the double-blind placebo-controlled treatment period (placebo, n = 134; ALO-02, n = 146). Significant improvement was observed for all SF-36v2 subscales and component scores (p < 0.005) and the EQ-5D-3L summary index and visual analog scale (p < 0.0001) during the titration period. Improvement was also significant (p < 0.0001) for all WPAI:SHP outcomes except 'work time missed due to CLBP' for the titration period. Significant differences favoring ALO-02 compared with placebo were only observed for the SF-36v2 Bodily Pain subscale (p ≤ 0.0232; ITT population) during the double-blind treatment period and the overall study period (screening to the end of the double-blind treatment period). The percentage change in activity impairment due to low back pain subscale of the WPAI:SHP significantly favored ALO-02 compared with placebo for the ITT population when considering the overall study period (p = 0.0040).

Conclusions: HRQL, work productivity, and activity impairment may be improved with ALO-02 treatment.

Trial registration: ClinicalTrials.gov NCT01571362 , registered April 3, 2012.

Keywords: Abuse-deterrent opioids; Chronic low back pain; Naltrexone; Oxycodone and extended-release opioid; Patient-reported outcomes.

Conflict of interest statement

Ethics approval and consent to participate

Informed consent and institutional review board approval were obtained before study initiation.

Consent for publication

No individual patient level data are presented in the manuscript.

Competing interests

Elizabeth T. Masters, Alexandra I. Barsdorf, Almasa Bass, Glenn Pixton, Jacquelyn G. Wilson, and Gernot Wolfram are full-time employees of Pfizer and hold stock and/or stock options. Arnold J. Weil recently served as a medical consultant for Adcock Ingram, Iroko, and Ferring Pharmaceuticals.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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