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Patient-centered Outcomes in Participants of a Buprenorphine Monthly Depot (BUP-XR) Double-blind, Placebo-controlled, Multicenter, Phase 3 Study

Ling, Walter MD; Nadipelli, Vijay R. MS; Solem, Caitlyn T. PhD; Ronquest, Naoko A. PhD; Yeh, Yu-Chen MS; Learned, Susan M. MD; Mehra, Vishaal MD; Heidbreder, Christian PhD

doi: 10.1097/ADM.0000000000000517
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Objective: Opioid use disorder (OUD) is associated with physical, social, psychological, and economic burden. This analysis assessed the effects of RBP-6000, referred to as BUP-XR (extended-release buprenorphine), a subcutaneously injected, monthly buprenorphine treatment for OUD compared with placebo on patient-centered outcomes measuring meaningful life changes.

Methods: Patient-centered outcomes were collected in a 24-week, phase 3, placebo-controlled study assessing the efficacy, safety, and tolerability of BUP-XR 300/300 mg (6 × 300 mg) and 300/100 mg (2 × 300 mg followed by 4 × 100 mg) injections in treatment-seeking participants with moderate-to-severe OUD. Measures included the EQ-5D-5L, SF-36v2, Medication Satisfaction Questionnaire, employment/insurance status, and healthcare resource utilization (HCRU). Changes from baseline to end of study were compared across treatment arms, using mixed models for repeated measures.

Results: Participants receiving BUP-XR (n = 389) versus placebo (n = 98) had significantly greater changes from baseline on the EQ-5D-5L index (300/300 mg: difference = 0.0636, P = 0.003), EQ-5D-5L visual analog scale (300/300 mg: difference = 5.9, P = 0.017; 300/100 mg: difference = 7.7, P = 0.002), and SF-36v2 physical component summary score (300/300 mg: difference = 3.8, P < 0.001; 300/100 mg: difference = 3.2, P = 0.002). Satisfaction was significantly higher for participants receiving BUP-XR 300/300 mg (88%, P < 0.001) and 300/100 mg (88%, P < 0.001) than placebo (46%). Employment and percentage of insured participants increased by 10.8% and 4.1% with BUP-XR 300/300 mg and 10.0% and 4.7% with 300/100 mg but decreased by 12.6% and 8.4% with placebo. Participants receiving BUP-XR compared with placebo had significantly fewer hospital days per person-year observed.

Conclusions: These results show the feasibility of measuring patient-centered life changes in substance use disorder clinical studies. Participants receiving up to 6 monthly injections of BUP-XR, compared with placebo, reported better health, increased medication satisfaction, increased employment, and decreased healthcare utilization.

This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0

UCLA David Geffen School of Medicine, Department of Family Medicine, Center for Behavioral & Addiction Medicine, Los Angeles, CA (WL); Indivior Inc., Richmond, VA (VRN, SML, CH); Pharmerit International, Bethesda, MD (CTS); RTI Health Solutions, Research Triangle Park, NC (NAR); Pharmerit International, Newton, MA (YCY); Artemis Institute for Clinical Research, San Diego, CA (VM).

Send correspondence to Caitlyn T. Solem, PhD, Pharmerit International, 4350 East-West Highway, Suite 1100, Bethesda, MD 20814. E-mail: csolem@pharmerit.com

Received 25 October, 2018

Accepted 4 February, 2019

Supplemental digital content is available for this article. Direct URL citation appears in the printed text and is provided in the HTML and PDF versions of this article on the journal's Web site (www.journaladdictionmedicine.com).

This study was funded by Indivior Inc.

W.L. is a consultant for Indivior Inc, Alkermes, Camurus/Braeburn, Opiant and Titan Pharmaceuticals. V.R.N., S.M.L., and C.H. are employees of Indivior Inc. N.A.R. was an employee of Indivior Inc. at the time of study conduct. C.T.S. and Y.-C.Y. are employees of Pharmerit International and are consultants for Indivior Inc. V.M. was a clinical investigator for the RBP-6000 clinical trials and consultant for Indivior Inc.

The authors report no conflicts of interest

© 2019 American Society of Addiction Medicine