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Open-label BNX sublingual tablets for Opioid Dependence

Phase 4
Waitlist Available
Led By Kent Hoffman
Research Sponsored by Orexo AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study endpoint
Awards & highlights

Summary

The purpose of this study was to assess safety, efficacy, and treatment retention following extended treatment with OX219, a higher-bioavailability buprenorphine/naloxone (BNX) sublingual tablet formulation in opioid-dependent patients who completed 1 of 2 primary efficacy and safety studies of OX219.

Eligible Conditions
  • Opioid Dependence

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to dosing on day 1, at weeks 4, 8,12,16, 20, 24, and at study endpoint
This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to dosing on day 1, at weeks 4, 8,12,16, 20, 24, and at study endpoint for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patient Discontinuations Due to Treatment-Emergent Adverse Events
Number of Patients Reporting Treatment-Emergent Adverse Events
Number of Patients Reporting Treatment-Emergent Serious Adverse Events
+1 more
Secondary outcome measures
Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHP
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 5-6 of the WPAI:SHP
+4 more

Side effects data

From 2014 Phase 4 trial • 668 Patients • NCT01903005
3%
Constipation
3%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Safety Population

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-label BNX sublingual tabletsExperimental Treatment1 Intervention
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Buprenorphine
FDA approved

Find a Location

Who is running the clinical trial?

Orexo ABLead Sponsor
6 Previous Clinical Trials
1,562 Total Patients Enrolled
1 Trials studying Opioid Dependence
9 Patients Enrolled for Opioid Dependence
Worldwide Clinical TrialsOTHER
62 Previous Clinical Trials
13,882 Total Patients Enrolled
Kent HoffmanPrincipal InvestigatorTRY Research, 406 Lake Howell Road, Maitland, Florida 32751
~55 spots leftby Sep 2025
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