Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02896296 | Open-Label Treatment Extension Study | PHASE3 | COMPLETED | 208 | — | — | Aug 17, 2016 | Aug 23, 2017 | Nov 29, 2018 | 29 | United States |
| NCT02559973 | Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder | PHASE1 | COMPLETED | 47 | — | — | Sep 1, 2015 | Mar 1, 2016 | Jan 31, 2017 | 1 | United States |
| NCT03002961 | Single Ascending Dose Study of RBP-6000 | PHASE1 | COMPLETED | 48 | — | — | Jul 1, 2012 | Oct 1, 2013 | Dec 26, 2016 | 1 | United States |
| NCT02765867 | Single-dose, Study of RBP-6000 in Opioid Dependent Individuals | PHASE1 | COMPLETED | 18 | — | — | Nov 1, 2010 | May 1, 2011 | May 9, 2016 | 1 | United States |
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 or surgical 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) * pulse oximetry (%) * pulse rate (beats/min) * temperature (C)
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. The number of participants with TEAEs specific to laboratory tests are summarized.
Relative bioavailability will be assessed using AUC0-28days.
Relative bioavailability will also be assessed using Cmax
Safety will be assessed by AEs, ECGs, laboratory measurements, local injection site tolerability and vital signs
Individual plasma concentrations will be collected to compute PK parameters. The individual concentrations will be summarized using descriptive statistics.
Safety to be assessed by AEs, ECGs, laboratory measurements, local injection site tolerability and vital signs
The frequency of all adverse events (AE) and serious adverse events (SAE) deemed to be related to treatment.
| Arm | Type | Description |
|---|---|---|
| RBP-6000 (100/300 mg Flex) | EXPERIMENTAL | On Day 1 of the study all eligible subjects received a single subcutaneous (SC) injection of RBP-6000. Participants returned to the site for monthly injection visits every 28 days (-2/+7 days) for a total of up to 6 injections. Participants were not required to complete all 6 injections and could choose to terminate from the study at any time. For each injection, participants could receive either a dose of 100 mg RBP-6000 or 300 mg RBP-6000, based on the medical judgement of the investigator. |
| RBP-6000 - Light MW | EXPERIMENTAL | Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with a light molecular weight (MW) polymer. |
| RBP-6000 - Heavy MW | EXPERIMENTAL | Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with a heavy molecular weight (MW) polymer. |
| RBP-6000 - Intermediate MW | ACTIVE_COMPARATOR | Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with an intermediate molecular weight (MW) polymer (reference). |
| Cohort 1 | EXPERIMENTAL | Subjects to receive low dose of RBP-6000 subcutaneously as a single injection |
| Cohort 2 | EXPERIMENTAL | Subjects to receive medium dose of RBP-6000 subcutaneously as a single injection |
| Cohort 3 | EXPERIMENTAL | Subjects to receive high dose of RBP-6000 subcutaneously as a single injection |
| Cohort 4 | EXPERIMENTAL | Subjects would receive medium dose RBP-6000 as a single injection after up to 12 mg daily dosing of sublingual (SL) suboxone tablets for 7 days |
| RBP-6000 | EXPERIMENTAL | A single dose of RBP-6000 will be administered on Study Day 1 |
| Name | Type | Description |
|---|---|---|
| RBP-6000 | DRUG | Monthly injections subcutaneously on alternate sides of participant's abdomen. Dose could be adjusted from 100 mg to 300 mg (or the reverse) based on the medical judgment of the investigator. |
| SUBOXONE Sublingual Film | DRUG | Subjects will be dose-stabilized on SUBOXONE sublingual film prior to administration of RBP-6000. SUBOXONE sublingual film will be administered beginning after the subject is experiencing signs and symptoms of withdrawal on Day -8 and continue until Day -1. |
| Suboxone | DRUG | RBP-6000 injection after 7 days of SL Suboxone administration. Interventions as above with additional daily PK collections during Suboxone treatment prior to RBP-6000 administration |
Inclusion Criteria: 1. Provide written consent to participate in this study. 2. Completed the End of Study Visit for the RB-US-13-0003 study (NCT02510014). 3. Be considered eligible in the medical judgment of the Investigator. 4. Females: Women of childbearing potential (defined as all women who ar...