buprenorphine
buprenorphine: developed by 3 companies · 8 clinical trials tracked · 2 FDA decisions.
buprenorphine evidence translation
What we can confirm
2 FDA records · 8 tracked trials
What it means
What to watch
Prepared research question
What is verified about buprenorphine, and what remains unknown?
Traceable citations · Unknowns marked
See linked entities and source evidence5 indications · 3 study sponsors
Related indications
Development Pipeline (4)
| Company | Phase |
|---|---|
| BIODELIVERY SCIENCES INTERNATIONAL INC (BDSI) Management of pain severe enough to require daily, around-th… | Approved |
| COLLEGIUM PHARMACEUTICAL, INC (COLL) Severe and persistent pain that requires an extended treatme… | Approved |
| Viatris Inc (VTRS) | Approved |
| Viatris Inc (VTRS) | Approved |
Clinical Trials (8)
Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
Primary endpoint: PrEP adherence, time to dropout
Buprenorphine for Analgesia in Older Adults With Acute Fractures in the Emergency Department: a Randomized Controlled Study
Primary endpoint: Difference in pain scores
Examining Analgesic Synergy and Efficacy in Trauma Care-A Randomized, Control Study of Buprenorphine Versus Oxycodone in Multimodal Pain Control Regimens
Primary endpoint: The Numeric Rating Scale (NRS) Pain Scores
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study With a Separate Open-label Cohort to Evaluate the Efficacy and Safety of Brenipatide as Adjunctive Treatment to Transmucosal Buprenorphine With or Without Naloxone in Early Recovery of Participants With Opioid Use Disorder (RENEW-Op-1)
Primary endpoint: Percentage of Weeks of Abstinence from Opioid Use Defined by Both Negative Urine Drug Screen (UDS) and no Self-Report of Opioid use Based on Timeline Followback (TLFB)
Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment - A Pragmatic Hybrid Effectiveness/Implementation Trial
Primary endpoint: Number of days of continuous treatment with study site clinician-prescribed methadone or buprenorphine, as randomized, during the 168 days post-randomization among RCT participants.
Opioid Use Disorder Treatment Linkage at Strategic Touchpoints Using Buprenorphine
Primary endpoint: OUD treatment entry (number [%] of participants who enter OUD treatment)
Neurocomputational Mechanisms of Mood Improvement
Primary endpoint: BOLD Responses in the vmPFC-VS circuit
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Primary endpoint: M/P ratio
FDA Decisions2 records
Frequently asked questions
Who is developing buprenorphine?
buprenorphine is being developed by BIODELIVERY SCIENCES INTERNATIONAL INC, COLLEGIUM PHARMACEUTICAL, INC, Viatris Inc.
How many clinical trials involve buprenorphine?
BioSniper tracks 8 clinical trials involving buprenorphine.
What is buprenorphine's latest FDA decision?
The most recent tracked FDA decision for buprenorphine is Approval for 1 INDICATIONS AND USAGE Buprenorphine sublingual tablet is indicated for the treatment of opioid dependence and is preferred for induction. Buprenorphine sublingual tablet should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine sublingual tablet, contains buprenorphine, a partial opioid agonist, and is indicated for the treatment of opioid dependence and is preferred for induction. (1) Buprenorphine sublingual tablet should be used as par, dated May 3, 2021.