Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SUBOXONE film · 1 trial · 2 indications
TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent one of the outcomes listed in this definition.
Vital signs include * systolic blood pressure (mmHg) * diastolic blood pressure (mmHg) * respiratory rate (breaths/minute) * weight (kg) * body mass index (kg/m\^2) * waist-to-hip ratio Baseline is defined as the last non-missing value prior to subcutaneous injection of RBP-6000 on Day 1.
The C-SSRS asks questions of study participants regarding whether they had suicidal ideation and/or suicidal behavior since the last visit using the electronic version of the scale. Only the most severe assessment is reported in this summary. Participants who experienced suicidal ideation and suicidal behavior are only summarized in the suicidal behavior since behavior is more severe than ideation. C-SSRS baseline version was completed during the screening visit. C-SSRS 'since-last-visit' version was completed weekly for the first month and at least every month until the end of the study. Shift table category titles are structured as: baseline category/treatment category. The category 'No Suicidal Ideation or Behaviour' has been abbreviated as 'No Suicidal I or B'.
Injection site pain as measured by participant-reported VAS. The participant-reported VAS for injection site pain was measured on a 100 mm scale with 'no pain' at 0 mm and 'strongest pain ever' at 100 mm (total scale of 0-100). Participants marked where along the scale reflected their localized injection pain. The injection site pain VAS scores were obtained (after the completion of the injection) within 1 minute and at 5, 10, 15, 30 and 60 minutes (+- 5 minutes). The timing of the injection site pain VAS should have been measured from the end of the injection. Data represents the worst pain recorded for each participant across all injections and all VAS records. The mean value is presented. De Novo subjects were given injections on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281 and 309. Roll-over subjects were given injections on Days 1, 29, 57, 85, 113, 141.
| Arm | Type | Description |
|---|---|---|
| Roll-over Subjects | EXPERIMENTAL | Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period. |
| De Novo Subjects | EXPERIMENTAL | Subjects who did not participate in RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 12 months in the Treatment period. |
| Name | Type | Description |
|---|---|---|
| SUBOXONE sublingual film | DRUG | SUBOXONE (buprenorphine sublingual film) is used for induction therapy on Days -14 to -12. Participants then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to starting the Treatment Period. |
| RBP-6000 | DRUG | Injections administered subcutaneously every 28 days on alternate sides of participant's abdomen starting at 300 mg. Subsequent doses of RBP-6000 could be adjusted down to 100 mg with the possibility of adjusting back up to 300 mg based on the medical judgment of the investigator. De novo subjects receive up to 12 injections and roll-over subjects receive up to 6 injections. |
Inclusion Criteria: De novo subjects: * Seeking treatment for opioid use disorder (OUD) and for the previous 3 months meet the Diagnostic and Statistical Manual 5 (DSM-5) criteria for moderate or severe OUD * Appropriate candidate for opioid partial-agonist treatment * BMI between 18 and 35, inclu...
SUBOXONE film is used for the treatment of Opioid Use Disorder. It is a small molecule product developed by Indivior Pharmaceuticals, Inc. The film is intended for patients seeking treatment for opioid-related disorders, as studied in a Phase 3 clinical trial.
SUBOXONE film is developed by Indivior Pharmaceuticals, Inc., which trades under the ticker INDV. The company conducted a Phase 3 clinical trial to evaluate the safety and tolerability of the product in subjects with Opioid Use Disorder.
SUBOXONE film is in Phase 3 clinical development. It has completed one Phase 3 trial, which was a controlled study with 775 participants. The product is investigational and not yet approved, as it remains in clinical development.
SUBOXONE film has one completed Phase 3 clinical trial, identified as NCT02510014. This study, titled 'Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder,' enrolled 775 participants in the United States.
SUBOXONE film contains buprenorphine, as indicated by the clinical trial title referencing depot buprenorphine. The study evaluated the safety and tolerability of this buprenorphine formulation in subjects with Opioid Use Disorder.