Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support. FDA label
Also known as Buprenorphine buccal film, Buprenorphine HCl buccal film, EN3409, BEMA Buprenorphine, BELBUCA, buprenorphine buccal soluble film, Buprenorphine HCl buccal soluble film
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...
Top 1 of 5 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE2 | LY4065967 |
Buprenorphine is being studied for the treatment of pain, including dental pain, low back pain, and general pain. Collegium Pharmaceutical, Inc. is developing a buprenorphine HCl buccal film formulation for these pain indications. The clinical program has focused on patients with chronic low back pain and on switching patients from other chronic opioid therapies.
Buprenorphine targets the mu opioid receptor (OPRM1) and the kappa opioid receptor (OPRK1), where it acts as an agonist. Activity at OPRM1 is associated with analgesic effects, while engagement of OPRK1 may influence pain signaling and tolerability. This dual receptor activity distinguishes it from agents selective for a single opioid receptor.
Collegium Pharmaceutical, Inc. (ticker: COLL) is the developer of the buprenorphine HCl buccal film described in this clinical program. The company has sponsored the trials evaluating this formulation in pain indications. Buprenorphine itself is an established active pharmaceutical ingredient, and multiple companies market other buprenorphine products.
Buprenorphine HCl buccal film is in clinical development, with a Phase 2 trial and three Phase 3 trials completed in pain indications. It is investigational, and the completed studies evaluated tolerability and efficacy in opioid-naive and opioid-experienced patients with low back pain and other pain conditions.
Completed trials include NCT01871285, a Phase 2 tolerability study of switching patients on chronic opioid therapy to buprenorphine HCl buccal film; NCT01675167, a Phase 3 efficacy study in opioid-experienced subjects; NCT01633944, a Phase 3 efficacy study in opioid-naive subjects; and NCT01256450, a Phase 3 efficacy and safety study in low back pain. All were conducted in the United States.
Across the reported studies, 1,567 patients were enrolled. The largest trials were NCT01675167 with 815 participants and NCT01633944 with 752 participants, both Phase 3 studies in low back pain. The Phase 2 switching study, NCT01871285, enrolled 39 subjects, and NCT01256450 enrolled 334.