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BEMA · 1 trial · 2 indications
Pain intensity (using an 11-point \[0 = no pain to 10 = worst pain\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo |
| BEMA™ Fentanyl | EXPERIMENTAL | BioErodible MucoAdhesive (BEMA) Fentanyl |
| Name | Type | Description |
|---|---|---|
| BEMA™ | DRUG | BioDelivery Sciences International, Inc. (BDSI) has developed BioErodible MucoAdhesive (BEMA) Fentanyl, an alternative product to OTFC that does not require the subject to continuously paint the inside of the mouth with the dosage form. The BDSI product is a small soluble film that is placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the film readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of the film are water soluble, so the entire dosage form dissolves within 30 minutes of application. |
| Placebo | DRUG | - |
Inclusion Criteria: * Male or non-pregnant and non-lactating female. A female of child-bearing potential is eligible to participate in this study if she is using an acceptable method of birth control. * 18 years or older * Patient must have pain associated with cancer or cancer treatment. * Patient...
BEMA is an investigational small molecule being developed for the treatment of pain, specifically breakthrough pain in cancer patients. It is a fentanyl formulation delivered via a buccal membrane. The drug is currently in Phase 3 clinical development and has completed one trial in this indication.
BEMA targets the mu-opioid receptor, as it contains fentanyl, a potent opioid agonist. By binding to this receptor, it modulates pain signaling pathways to provide analgesic effects. This mechanism is relevant for managing breakthrough pain episodes in cancer patients.
BEMA is being developed by Collegium Pharmaceutical, Inc., a company traded on the NASDAQ under the ticker symbol COLL. The company is responsible for the clinical development and regulatory strategy for this investigational drug candidate.
BEMA is in Phase 3 clinical development. It has completed one Phase 3 trial, and it remains investigational, meaning it has not yet been approved by regulatory authorities. The drug is being studied for the management of breakthrough pain in cancer patients.
BEMA has one completed clinical trial, identified as NCT00293033, titled 'Study of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects.' This was a Phase 3, randomized, double-blind, placebo-controlled study conducted in the United States with 152 participants.
BEMA is a formulation of fentanyl, a well-known opioid analgesic. It is designed to deliver fentanyl through the buccal mucosa for rapid absorption. While the active ingredient is fentanyl, BEMA is a specific drug product being developed by Collegium Pharmaceutical for breakthrough pain in cancer.