Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed for the treatment of opioid dependence. It is a buccal film formulation of buprenorphine combined with naloxone, designed to deliver the medication through the lining of the cheek. The drug is intended to help manage opioid dependence, a psychiatric condition.
BEMA Buprenorphine NX is being developed by Collegium Pharmaceutical, Inc., a company traded on the stock exchange under the ticker symbol COLL. Collegium is responsible for the research and clinical development of this investigational drug for opioid dependence.
BEMA Buprenorphine NX is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and tolerability in patients with opioid dependence.
BEMA Buprenorphine NX has been studied in one completed Phase 2 clinical trial with the identifier NCT01666119. This open-label study assessed the safety and tolerability of the drug in 249 opioid-dependent subjects in the United States. The trial enrolled adults aged 18 years and older.
BEMA Buprenorphine NX is a specific buccal film formulation of buprenorphine combined with naloxone. The name BEMA refers to the BioErodible MucoAdhesive delivery system used in the film. While it contains buprenorphine, it is a distinct product being developed by Collegium Pharmaceutical.