Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Buprenorphine · 1 trial · 3 indications
Engagement in OUD is defined as coverage with a legitimately prescribed MOUD on that 34th day regardless of the source of prescribed MOUD coverage (e.g., formalized treatment program, primary care, jail, etc.).
| Arm | Type | Description |
|---|---|---|
| Interventional | EXPERIMENTAL | Single subcutaneous injection of a 28-day formulation of extended-release buprenorphine within 72 hours of anticipated hospital discharge. |
| Treatment as Usual | ACTIVE_COMPARATOR | Community standard of care that includes initiation of either methadone, sublingual (SL) buprenorphine, or naltrexone prior to hospital discharge. |
| Name | Type | Description |
|---|---|---|
| Extended Release Buprenorphine | DRUG | XR-BUP administration prior to hospital discharge will increase engagement in OUD care on the 34th day following hospital discharge more than is currently afforded by ACS TAU approaches (e.g., methadone, SL-BUP, and naltrexone). |
| Treatment as Usual | DRUG | Community standard medication for opioid use disorder (e.g., methadone, sublingual buprenorphine, naltrexone) initiated prior to hospital discharge. |
Inclusion Criteria: 1. Hospitalized. 2. At least 18 years of age. 3. Meet Diagnostic and Statistical Manual (DSM-5) criteria for moderate or severe OUD. 4. Willing to initiate MOUD, including buprenorphine. 5. Able to speak English sufficiently to understand the study procedures and provide written...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 3 | PHASE3 | LY3537031 |
| Clearmind Medicine Inc. | CMND | 1 | PHASE1 | CMND-100 |
| Brainsway Ltd Sponsored ADR | BWAY | 1 | N/A | Undisclosed |
| Cooper Companies, Inc. | COO | 1 | - | Undisclosed |
| Masimo Corporation | MASI | 1 | N/A | Undisclosed |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | N/A | Undisclosed |
Buprenorphine is used for Substance Use Disorder, specifically including moderate and severe Opioid Use Disorder. It is being developed as a small molecule treatment in the psychiatry therapeutic area. The drug is currently in Phase 2 clinical development and is considered investigational.
Buprenorphine is being developed by National Healthcare Corp., which trades under the ticker NHC. The company is conducting clinical trials for the drug in the United States for the treatment of Substance Use Disorder.
Buprenorphine is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed for the treatment of Substance Use Disorder.
Buprenorphine has one completed clinical trial, NCT04345718, titled EXHIT ENTRE Comparative Effectiveness Trial. This Phase 2 study enrolled 344 participants in the United States with moderate or severe Opioid Use Disorder. The trial was active-controlled and randomized, though not double-blinded.
Buprenorphine is a small molecule developed for Substance Use Disorder. As a small molecule, it is designed to interact with biological targets to produce its therapeutic effect. The specific molecular target has not been disclosed in the available information.