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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, Buprenorphine buccal film, Buprenorphine HCl buccal film, BEMA Buprenorphine, BELBUCA
EN3409 · 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...
Top 1 of 5 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE2 | LY4065967 |
EN3409 is an investigational small molecule being developed for the treatment of low back pain. It is also being studied for osteoarthritis and neuropathic pain. The drug is currently in Phase 3 clinical development and is not yet approved by the FDA.
EN3409 is being developed by Collegium Pharmaceutical, Inc., a company traded on the NASDAQ under the ticker symbol COLL. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for pain-related conditions.
EN3409 is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet received FDA approval. The Phase 3 program includes a completed long-term open-label safety study, and the drug remains under clinical investigation.
EN3409 has one completed Phase 3 clinical trial registered under NCT01755546. This was a long-term open-label safety study that enrolled 304 participants with low back pain, osteoarthritis, or neuropathic pain. The trial was conducted in the United States and involved adults aged 18 years and older.
The completed clinical trial for EN3409, NCT01755546, was an uncontrolled, open-label study. It was not randomized and did not use a double-blind design. The study had no control group, meaning all participants received the investigational drug.