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.
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.
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.
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.
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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: email@example.com
Received 25 October, 2018
Accepted 4 February, 2019
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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