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Also known as bioerodible mucoadhesive, fentanyl buccal soluble film, ONSOLIS, bioerodible mucoadhesive system
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 developed for the treatment of pain, including breakthrough pain in cancer patients on chronic opioid therapy, and for respiratory depression. It is being studied in oncology settings. It is not described as approved and remains in clinical development.
BEMA Fentanyl is being developed by Collegium Pharmaceutical, Inc., which trades under the ticker COLL. The company is the sponsor of the clinical program evaluating the drug in pain and respiratory depression indications.
BEMA Fentanyl is in Phase 3 clinical development. Its trials are listed as completed, and no active trials are currently recorded. The drug is investigational and has not been described as approved by the FDA.
BEMA Fentanyl has been studied in two completed Phase 3 trials. NCT00293020 evaluated the safety of BEMA Fentanyl for breakthrough pain in cancer subjects on chronic opioid therapy, enrolling 244 participants in the United States. NCT00696137 was a long-term extension study in respiratory depression.
The BEMA Fentanyl clinical program enrolled 244 participants in its main Phase 3 safety study, NCT00293020, which examined breakthrough pain in cancer patients on chronic opioid therapy. A separate long-term extension study, NCT00696137, enrolled 5 participants.