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Label indication BELBUCA is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. BELBUCA buccal film contains buprenorphine, a partial opioid agonist. FDA label
Also known as buprenorphine buccal soluble film, Buprenorphine, BELBUCA, Buprenorphine HCl buccal film, Buprenorphine HCl buccal soluble film, Buprenorphine buccal film, EN3409
BEMA Buprenorphine · 7 trials · 5 indications
The NRS Pain intensity score is a segmented version of a visual analog scale used to measure pain. The scale is from 0 (no pain) to 10. Scores between greater than 0 and 3 are considered mild pain, scores from greater than 3 to 6 are moderate and greater than 6 to 10 are severe. The daily average is calculated and the change from baseline at week 48 is presented.
Change in pain intensity = average of daily pain scores from the last 7 days prior to week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
The NRS Pain intensity score is a segmented version of a visual analog scale used to measure pain. The scale is from 0 (no pain) to 10. Scores between greater than 0 and 3 are considered mild pain, scores from greater than 3 to 6 are moderate and greater than 6 to 10 are severe. The daily average is calculated and used to calculate the change from baseline at week 52.
Change in pain intensity = average of daily pain scores from the last 7 days prior to week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
A responder is defined as a subject whose maximum (across all time points) clinical opiate withdrawal scale (COWS) total score is ≥13. COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal.
Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal. The maximum COWs total score is defined as the maximum COWs total score across all time points during the corresponding treatment period after study drug administration for each subject.
Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal. The change from baseline in maximum COWS total score is determined as the difference between the maximum COWs total score and the baseline COWs total score.
Time-weighted sum of pain intensity difference from baseline to 8 hours (SPID-8) where total score ranges from -80 (worst) to 80 (best) and a higher value indicates greater pain relief. Pain intensity was recorded using an 11-point numeric rating scale (NRS), where 0=none and 10=worst pain imaginable, in response to "What is your pain level at this time?"
| Arm | Type | Description |
|---|---|---|
| EN3409 | EXPERIMENTAL | Buprenorphine HCI Buccal File at doses ranging from 300-900 mcg twice daily |
| Placebo Buccal Film | PLACEBO_COMPARATOR | Twice Daily Dosing |
| Buprenorphine HCl Buccal Film | EXPERIMENTAL | Twice Daily Dosing |
| Placebo | PLACEBO_COMPARATOR | Twice Daily Dosing |
| BEMA Buprenorphine | EXPERIMENTAL | buprenorphine buccal soluble film |
| BEMA Placebo | PLACEBO_COMPARATOR | placebo buccal soluble film |
| MSE Dose Group 1 | EXPERIMENTAL | Morning and evening dose of buprenorphine HCl buccal film (300 μg) + placebo capsule in one period, and then placebo film + over-encapsulated ATC opioid (morphine sulfate or oxycodone) at 50% MSE daily dose in the alternate period |
| MSE Dose Group 2 | EXPERIMENTAL | Morning and evening dose of buprenorphine HCl buccal film (450 μg) + placebo capsule in one period, and then placebo film + over-encapsulated ATC opioid (morphine sulfate or oxycodone) at 50% MSE daily dose in the alternate period |
| Standard Opioid | ACTIVE_COMPARATOR | Oxycodone 5-mg oral capsule and 2 buccal placebo films |
| High Dose buprenorphine HCl buccal film | EXPERIMENTAL | Buprenorphine HCl buccal film 0.5-mg modified formulation 1, buccal placebo film, and oral placebo capsule |
| Mid Dose buprenorphine HCl buccal film | EXPERIMENTAL | Buprenorphine HCl buccal film 0.5-mg modified formulation 2, buccal placebo film, and oral placebo capsule |
| Low Dose buprenorphine HCl buccal film | EXPERIMENTAL | Buprenorphine HCl buccal film 0.25-mg modified formulation 2, buccal placebo film, and oral placebo capsule |
| Name | Type | Description |
|---|---|---|
| EN3409 | DRUG | Open-Label Buprenorphine HCI Buccal Film at doses 300-900 mcg twice daily |
| Buprenorphine | DRUG | Buprenorphine HCl Buccal Film at doses ranging from 150-900 mcg twice daily |
| Placebo | DRUG | Matching Placebo Buccal Film twice daily |
| BEMA Buprenorphine | DRUG | buccal soluble film; applied to the buccal mucosa twice daily |
| Placebo film | DRUG | Matching placebo buccal film |
| Oxycodone | DRUG | Oxycodone extended-release (ER) or immediate-release (IR) 5, 10, 15, 20, and 30 mg over-encapsulated oral tablets |
| Morphine sulfate | DRUG | Morphine sulfate 15, 30, and 60 mg ER or 15 and 30 mg IR over-encapsulated oral tablets |
| Placebo capsule | DRUG | Oral placebo capsules matching the over-encapsulated morphine sulfate and oxycodone tablets |
Inclusion Criteria: * Female subjects who are practicing abstinence or using a medically acceptable form of contraception or have been postmenopausal, biologically sterile, or surgically sterile for more than 1 year * Male subjects who are practicing abstinence, surgically sterile, or are using a m...
BEMA Buprenorphine is an investigational small molecule developed by Collegium Pharmaceutical, Inc. (ticker COLL) for the treatment of pain. It is being studied in a Phase 3 clinical program and is not yet approved. The name BEMA refers to the drug delivery technology used in the product.
BEMA Buprenorphine is being developed for the treatment of pain, including chronic pain. The Phase 3 trial enrolled subjects with low back pain, osteoarthritis, and neuropathic pain. It is an investigational therapy and has not been approved for any indication.
BEMA Buprenorphine is being developed by Collegium Pharmaceutical, Inc., which trades under the ticker COLL. Collegium is the sponsor of the clinical program for this investigational pain therapy.
BEMA Buprenorphine is in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The drug remains investigational and has not been approved by the FDA for any indication.
BEMA Buprenorphine has been studied in one completed Phase 3 trial, NCT01298765, titled Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain. The trial enrolled 302 subjects in the United States and included patients with low back pain, osteoarthritis, and neuropathic pain.