Effects of a Higher-bioavailability Buprenorphine/Naloxone Sublingual Tablet Versus Buprenorphine/Naloxone Film for the Treatment of Opioid Dependence During Induction and Stabilization: A Multicenter, Randomized Trial

Gunderson, Erik W.; Hjelmström, Peter; Sumner, Michael

doi:10.1016/j.clinthera.2015.08.025

Cited by 18 publications

(13 citation statements)

References 20 publications

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“…the treatment phase in which the drop-out rate is highest. This was demonstrated in a recent large induction study with SL BUP-NLX which reported that approximately 25% of patients withdrew from treatment during the first 15 days [49]. In addition, approximately 24% of patients withdrew during the 7-14 day SL BUP run-in period in a trial of an extended-release BUP formulation [7].…”

Section: Discussionmentioning

confidence: 92%

Optimal dose of buprenorphine in opioid use disorder treatment: a review of pharmacodynamic and efficacy data

Hjelmström¹,

Nordbeck²,

Tiberg³

2020

Drug Development and Industrial Pharmacy

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Context: There is currently no consensus regarding optimal dose or dose-range of buprenorphine (BUP) for treatment of opioid use disorder (OUD). Objective: To elucidate the relationship between BUP dose and opioid receptor blockade, retention in treatment and illicit opioid drug use. Methods: Systematic review of the scientific literature through searches in the databases MEDLINE and PubMed. Results: The review of the opioid receptor blockade studies did not find evidence that a daily sublingual (SL) BUP tablet dose higher than 16 mg confers added blockade benefit, while doses under 8 mg are insufficient to produce opioid receptor blockade. The data are inconclusive regarding the relative effectiveness of an 8 mg SL BUP tablet dose versus a 16 mg SL BUP tablet dose in terms of opioid receptor blockade. The review did not establish any clear relationship between BUP dose and treatment retention or illicit opioid use. Conclusions: The BUP dose in treatment of OUD should be individualized based on a continuous clinical benefit-risk assessment. Further research is needed to better understand the relationship between dose and efficacy over time in patients with this complex disorder.

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Section: Discussionmentioning

confidence: 92%

Optimal dose of buprenorphine in opioid use disorder treatment: a review of pharmacodynamic and efficacy data

Hjelmström¹,

Nordbeck²,

Tiberg³

2020

Drug Development and Industrial Pharmacy

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“…Findings from 2 randomized studies conducted in 1068 patients with opioid dependence provide robust evidence supporting the safety and efficacy of BNX-RDT during induction and maintenance ( Webster et al, 2014 ; Gunderson et al, 2015 ). The primary objective of the current extension study, which included patients who completed the primary efficacy trials, was to further evaluate the safety of longer-term treatment with BNX-RDT using assessments of treatment-emergent adverse events (TEAEs).…”

mentioning

confidence: 99%

Safety of a Rapidly Dissolving Buprenorphine/Naloxone Sublingual Tablet (BNX-RDT) for Treatment of Opioid Dependence: A Multicenter, Open-label Extension Study

Hoffman

Peyton

Sumner

2017

Journal of Addiction Medicine

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Objective:To assess the safety of rapidly dissolving buprenorphine/naloxone sublingual tablets (BNX-RDT) in opioid-dependent patients.Methods:This open-label, 24-week extension study enrolled patients who completed primary trials of BNX-RDT. Daily tablet doses ranged from 5.7 to 17.1 mg. The primary endpoint was safety; secondary assessments included opioid cravings, addiction severity, health-related quality of life (QOL), and workplace productivity at screening (final day of the primary trials) through study end, with changes measured from baseline of the primary trials.Results:In all, 665 patients received treatment; 292 (43.9%) completed the study. A total of 258 patients (38.8%) reported 557 treatment-emergent adverse events, most commonly headache (3.2%) and constipation (3.0%). Craving scores showed continued improvement on 100-mm visual analog scale (mean change from primary trial baseline, −52.8 at screening; mean change from extension trial baseline, −60.5 at week 24). Reductions in addiction severity from baseline of both the primary and extension trial were maintained through week 24 on multiple assessments, as were improvements in QOL on Short Form 36. Employment increased by 15% and mean (SD) hours worked per week increased by 4.6 (20.1) from baseline to study end. Mean (SD) scores for impact of opioid dependence on work productivity improved from 4.7 (3.0) at baseline to 0.9 (1.8) at study end (11-point scale).Conclusions:Extended treatment with BNX-RDT demonstrated a safety profile similar to other BNX formulations, reduced opioid cravings, and improved both QOL and work productivity. Continued treatment may enable patients to advance in recovery and return to normal functioning.

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“…The ISTART was a prospective, randomized, parallel-group, multicenter, noninferiority trial conducted at 43 centers in the United States, from August 2013 to April 2014; the primary efficacy and key secondary outcomes of ISTART were previously reported ( Gunderson et al, 2015 ). The study comprised a 2-day induction phase and a 20-day stabilization phase (Fig.…”

Section: Methodsmentioning

confidence: 99%

“…Safety assessments were performed using the safety population, which was defined as all patients who had at least 1 dose of study medication. As the coprimary endpoints of ISTART were retention in treatment at days 3 and 15 ( Gunderson et al, 2015 ), the handling of dropouts or missing data was not an issue. All secondary efficacy analyses were based on observed data in the full analysis population.…”

Section: Methodsmentioning

confidence: 99%

Efficacy of Buprenorphine/Naloxone Rapidly Dissolving Sublingual Tablets (BNX-RDT) After Switching From BNX Sublingual Film

Gunderson

Sumner

2016

Journal of Addiction Medicine

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Objectives:The aim of the study was to evaluate treatment retention, efficacy, and preference ratings among opioid-dependent patients transitioning between a buprenorphine/naloxone rapidly dissolving sublingual tablet formulation (BNX-RDT) and BNX film.Methods:After a 2-day, blinded, fixed-dose induction with BNX-RDT (5.7/1.4 mg and 5.7/1.4 or 11.4/2.8 mg, respectively) or buprenorphine (8 mg and 8 or 16 mg, respectively), patients received open-label titrated doses of BNX-RDT or BNX film (generic buprenorphine induction group) during days 3 to 14. On day 15, patients switched treatment (using a conversion ratio of 5.7–8 mg) and continued switched treatment through day 22. Assessments included treatment retention, opioid withdrawal (Clinical and Subjective Opiate Withdrawal scales), opioid cravings (0–100 visual analog scale [VAS]), and preference ratings.Results:Of the 287 patients who switched from BNX-RDT to BNX film and 279 patients who switched from BNX film to BNX-RDT at day 15, 8.7% and 6.1% withdrew, respectively. Reductions in opioid withdrawal and cravings were similar with both formulations through day 15; after switching treatment, reductions were maintained through day 22 in both groups. Preference ratings at day 22 (patients had received both formulations) favored BNX-RDT for taste, mouthfeel, ease of administration, and overall preference (all P < 0.0001).Conclusions:In both patient groups who switched treatment at day 15, more than 90% were retained in treatment, and reductions in opioid withdrawal and cravings were sustained. A significant majority of patients preferred BNX-RDT over BNX film, the clinical impact of which requires further study.

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Effects of a Higher-bioavailability Buprenorphine/Naloxone Sublingual Tablet Versus Buprenorphine/Naloxone Film for the Treatment of Opioid Dependence During Induction and Stabilization: A Multicenter, Randomized Trial

Cited by 18 publications

References 20 publications

Optimal dose of buprenorphine in opioid use disorder treatment: a review of pharmacodynamic and efficacy data

Optimal dose of buprenorphine in opioid use disorder treatment: a review of pharmacodynamic and efficacy data

Safety of a Rapidly Dissolving Buprenorphine/Naloxone Sublingual Tablet (BNX-RDT) for Treatment of Opioid Dependence: A Multicenter, Open-label Extension Study

Efficacy of Buprenorphine/Naloxone Rapidly Dissolving Sublingual Tablets (BNX-RDT) After Switching From BNX Sublingual Film

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