Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BEMA Fentanyl · 2 trials · 3 indications
Efficacy was not measured in this study as the intention was to evaluate long term safety in this population. The number of deaths in the long term follow-up will be reported.
After the first dose of BEMA Fentanyl, all adverse events were recorded and summarized.
| Arm | Type | Description |
|---|---|---|
| BEMA Fentanyl | EXPERIMENTAL | BEMA Fentanyl |
| 1 | EXPERIMENTAL | BEMA Fentanyl |
| Name | Type | Description |
|---|---|---|
| BEMA Fentanyl | DRUG | buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily |
Inclusion Criteria: 1. previously qualified for and participated in study FEN-202 for at least 2 weeks, 2. wish to continue using BEMA Fentanyl for treatment of breakthrough pain episodes, and 3. provide signed informed consent at screening prior to any study procedures. Exclusion Criteria: 1. th...
BEMA Fentanyl is an investigational small molecule being developed for the management of breakthrough pain in cancer patients on chronic opioid therapy. It is also being studied for respiratory depression. The drug is in Phase 3 clinical development and is not yet approved by the FDA.
BEMA Fentanyl is being developed by Collegium Pharmaceutical, Inc., a company traded on the stock exchange under the ticker symbol COLL. The drug is currently in Phase 3 clinical trials for pain and respiratory depression.
BEMA Fentanyl is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials have been completed, including a study of its safety for breakthrough pain in cancer subjects on chronic opioid therapy.
BEMA Fentanyl has been studied in clinical trials registered as NCT00293020 and NCT00696137. The first trial, NCT00293020, was a Phase 3 study of the safety of BEMA Fentanyl for breakthrough pain in cancer subjects on chronic opioid therapy, with 244 participants. The second, NCT00696137, was a long-term extension study.
BEMA Fentanyl is a formulation of fentanyl, an opioid analgesic. The drug name includes 'Fentanyl' to indicate its active ingredient. It is being developed specifically for breakthrough pain in cancer patients, using a buccal delivery system.