Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BNX
BEMA Buprenorphine NX films · 1 trial · 1 indication
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...
BEMA Buprenorphine NX is an investigational small molecule developed for the treatment of opioid dependence. It is being studied in adults 18 years and older. The candidate is in Phase 2 clinical development and is not approved for commercial use.
BEMA Buprenorphine NX is being developed by Collegium Pharmaceutical, Inc., which trades under the ticker COLL. The company is the sponsor of the clinical program evaluating the candidate in opioid dependence.
BEMA Buprenorphine NX is in Phase 2 clinical development. One Phase 2 trial has been completed, and no trials are currently active. The candidate remains investigational and has not been approved by the FDA for any indication.
BEMA Buprenorphine NX has been evaluated in one completed Phase 2 trial, NCT01666119, titled An Open Label Study To Assess The Safety And Tolerability Of BEMA Buprenorphine NX In Opioid Dependent Subjects. The study enrolled 249 participants in the United States and was open label and uncontrolled.
No. BEMA Buprenorphine NX is investigational and has not been approved by the FDA. It is in Phase 2 clinical development for opioid dependence, with one completed trial and no active trials at this time.