buprenorphine
buprenorphine: sourced relationships with 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 evidence4 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (4)
| Company | Dated record stage |
|---|---|
| BIODELIVERY SCIENCES INTERNATIONAL INC (BDSI) Management of pain severe enough to require daily, around-th… | Approved |
| DR REDDYS LABORATORIES LTD (RDY) Reported 2020-07-17 · Current development: unknownSource | Approved |
| Viatris Inc (VTRS) Reported 2021-05-03 · Current development: unknownSource | Approved |
| Viatris Inc (VTRS) Reported 2021-05-03 · Current development: unknownSource | Approved |
Clinical Trial Registry Records (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 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
Which companies have sourced relationships with buprenorphine?
buprenorphine has dated SEC/FDA relationship records for BIODELIVERY SCIENCES INTERNATIONAL INC, DR REDDYS LABORATORIES LTD, 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.