Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Buprenorphine · 5 trials · 3 indications
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).
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 |
|---|---|---|
| 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 |
|---|---|---|
| Buprenorphine | DRUG | Buprenorphine HCl Buccal Film at doses ranging from 150-900 mcg twice daily |
| Placebo | DRUG | Matching Placebo Buccal Film 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: * Diagnosis of moderate to severe low back pain for ≥6 months * Treating CLBP with a stable daily maintenance dose of ATC opioid analgesic medication equivalent to ≥30 mg and ≤160 mg morphine sulfate equivalents (MSE) per day for ≥4 weeks. (Additional as needed \[PRN\] analgesic...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Hinge Health, Inc. Class A | HNGE | 1 | N/A | Undisclosed |
| Stryker Corporation | SYK | 1 | - | Undisclosed |
| Boston Scientific Corporation | BSX | 1 | N/A | Undisclosed |
| Aclarion, Inc. | ACON | 1 | - | Undisclosed |
| United Therapeutics Corporation | UTHR | 1 | N/A | Undisclosed |
| eHealth, Inc. | EHTH | 1 | N/A | Undisclosed |