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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01666119 | An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects | PHASE2 | COMPLETED | 249 | — | — | Aug 1, 2012 | Jan 1, 2013 | Apr 4, 2017 | 10 | United States |
Adverse events that occur in more than 2 subjects. Among the adverse events that occurred in \> 2 subjects, the total number of unique events that were experienced are reported.
| Arm | Type | Description |
|---|---|---|
| BEMA Buprenorphine NX films | EXPERIMENTAL | BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone)will be provided in 3.361 and 5.447 cm2 film sizes, respectively. |
| Name | Type | Description |
|---|---|---|
| BEMA Buprenorphine NX films | DRUG | BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone) will be provided in 3.361 and 5.447 cm2 film sizes, respectively. |
Inclusion Criteria: 1. Written informed consent obtained at Screening, prior to any study procedure being performed 2. Male or non-pregnant and non-nursing female. A female of childbearing potential is eligible to participate in this study if she is not pregnant, and is using an acceptable method o...