BUTRANS (buprenorphine)
Butrans helps patients with severe and persistent pain that requires continuous, long-term opioid therapy. It is used when other options, such as immediate-release opioids, are ineffective, not tolerated, or otherwise inadequate for managing pain. Because of the serious risks involved with opioids, this medication is reserved for those who have no other viable treatment alternatives. It is designed for around-the-clock management rather than as-needed use.
How BUTRANS Works
Buprenorphine is a partial agonist at the mu-opioid and ORL-1 (nociceptin) receptors, an antagonist at the kappa-opioid receptor, and an agonist at the delta-opioid receptor. While the specific contribution of each of these receptor interactions to the drug's clinical effect is not fully established, these combined actions define its analgesic profile.
Details
- Status
- Prescription
- First Approved
- 2010-06-30
- Routes
- TRANSDERMAL
- Dosage Forms
- FILM, EXTENDED RELEASE
BUTRANS Approval History
What BUTRANS Treats
1 indicationsBUTRANS is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
BUTRANS Boxed Warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUTRANS Addiction, Abuse, and Misuse Because the use of BUTRANS ® exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1) ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respirator...
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUTRANS Addiction, Abuse, and Misuse Because the use of BUTRANS ® exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1) ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of BUTRANS, especially during initiation or following a dosage increase . To reduce the risk of respiratory depression, proper dosing and titration of BUTRANS are essential. Misuse or abuse of BUTRANS by chewing, swallowing, snorting or injecting buprenorphine extracted from the transdermal system will result in the uncontrolled delivery of buprenorphine and pose a significant risk of overdose and death [see Warnings and Precautions (5.2) ]. Accidental Exposure Accidental exposure of even one dose of BUTRANS, especially in children, can result in a fatal overdose of buprenorphine [see Warnings and Precautions (5.2) ] . Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of BUTRANS and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.3) , Drug Interactions (7) ]. Neonatal Opioid Withdrawal Syndrome (NOWS) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions (5.4) ] . Opi
BUTRANS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to BUTRANS
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
81 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07420283 RENEW-Op-1 | 27348 J2S-MC-GZMG | Ph 2 | recruiting | A Study of Brenipatide in Participants With Opioid Use Disorder |
| NCT07176351 | 2000040545 | Ph 4 | not yet recruiting | Acceptability and Feasibility of Extended-Release Subcutaneous Buprenorphine on a Mobile Pharmacy Clinic |
| NCT07435077 EASE | IRB00140421 | Ph 4 | not yet recruiting | Examining Analgesic Synergy and Efficacy in Trauma Care |
| NCT04276259 RAISE | STUDY19050307 1R01MH122548-01 | Ph 4 | completed | Rapid Antidepressant Improvement Secondary to Excitatory Brain Responses |
| NCT03150173 O-BMT results posted | 2017-7484 R01DA044878 | Ph 2 | completed | Onsite Buprenorphine Treatment at Syringe Exchange Programs |
| NCT06316830 Optimal Bup | STUDY00000075 | Ph 2, Ph 3 | recruiting | Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose |
| NCT06086275 | 2023P002634 | Ph 1 | completed | Oral Buprenorphine as a Novel Low-dose Induction Strategy for Opioid Use Disorder |
| NCT06379984 ROLDI | 855013 | Ph 2 | recruiting | Rapid Outpatient Low-dose Initiation of Buprenorphine for OUD With Fentanyl Use |
| NCT03646058 BUPRIS | PHRC-N/2017/FJ-01 | Ph 3 | recruiting | Add-on Buprenorphine at Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode |
| NCT06494904 ED-ENVISION | UG1DA015831 UG1DA015831 | Ph 3 | recruiting | Standard Versus High Dose ED-Initiated Buprenorphine Induction |
| NCT04752384 results posted | PRO00040100 | Ph 2 | completed | Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients |
| NCT06406400 | D7460C00004 | Ph 1 | terminated | Drug-Drug Interaction and Safety of AZD4041 Study (Part 1) and Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AZD4041 Study in Opioid Use Disorder (Part 2). |
| NCT04116528 AFSP | 51536 | Ph 3 | active not recruiting | Opiate Suicide Study in Patients With Major Depression |
| NCT04571619 HOPE results posted | HOPE U01DK123813, U01DK123786 | Ph 2 | completed | HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis |
| NCT04981678 results posted | 1688818-1 U54GM115516-06 | Ph 4 | terminated | The Effect of Buprenorphine Continuation for Patients With Opioid Use Disorder |
| NCT03605342 results posted | MHBB-010-17F | Ph 2 | terminated | Optimal Treatment of Veterans With PTSD and Comorbid OUD |
| NCT06133114 | STUDY-22-01296 | Ph 4 | recruiting | Psychopharmacological Treatment of Emotional Distress |
| NCT05164549 EXPO | 255522 | Ph 3 | completed | Extended-release Pharmacotherapy for Opioid Use Disorder |
| NCT02187198 results posted | IP0040 | Ph 3 | completed | Buprenorphine Treatment for Opioid Dependence |
| NCT03232346 results posted | 7522 1R21DA042243 | Ph 3 | completed | A Strategy to Improve Success of Treatment Discontinuation in Buprenorphine Responders |
| NCT02543944 GBN results posted | 203970 R01DA039088 | Ph 2, Ph 3 | completed | Improving Treatment Outcomes for Prescription Opioid Dependence |
| NCT03492099 results posted | IRB00159636 | Ph 2 | completed | Assessing the Safety of Buprenorphine in People With Sickle Cell Disease |
| NCT03113409 results posted | #7456 | Ph 2, Ph 3 | terminated | Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol |
| NCT01733693 NEO | 2012-433 1R01DA032552-01A1 | Ph 4 | completed | Neurocognitive Effects of Opiate Agonist Treatment |
| NCT03608696 B-PHORE results posted | 18C.272 | Ph 1, Ph 2 | completed | Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure |
| NCT01843023 results posted | 1R01DA033391-01A1 R01DA033391 | Ph 4 | completed | Extended Release Naltrexone for Opioid-Dependent Youth |
| NCT02946073 CAM2038 results posted | HS-16-555 | Ph 3 | completed | Buprenorphine (CAM2038) in Subjects With a Recent History of Moderate to Severe Chronic Low Back Pain |
| NCT00634803 POD results posted | 0608001776 1R01DA024695-01A2 | Ph 1, Ph 2 | completed | Clinical Trial of Integrated Treatment for Pain and Opioid Dependence |
| NCT03380533 | 2960 | Ph 2, Ph 3 | completed | Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair |
| NCT04212065 | 2019H0354 | Ph 4 | withdrawn | Long Acting Subcutaneous vs Short Acting Sublingual Buprenorphine in Pregnant and Lactating Women |
| NCT02526212 G-BMT results posted | 2014-3580 R34DA039041 | Ph 3 | completed | Buprenorphine Group Medical Visits in Primary Care |
| NCT03740243 | 1175806 | Ph 4 | withdrawn | Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology |
| NCT02181231 IRLGreyB results posted | 201406016 IND 123020, IND 130774 | Ph 1, Ph 2 | completed | Buprenorphine Used With Treatment Resistant Depression in Older Adults |
| NCT03268278 EBPEA | UHClevelandMCBupStudy | Ph 1 | terminated | Efficacy of Buprenorphine on Postoperative Endodontic Analgesia |
| NCT02696434 results posted | ALK6428-A302 | Ph 3 | completed | Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL |
| NCT01114308 | PRO-806 1RC2DA028910-01 | Ph 3 | completed | A Six-Month Randomized Controlled Trial (RCT) of Probuphine Safety and Efficacy in Opioid Addiction |
| NCT00947466 BUP1501 | BUP1501 2008-002428-27 | Ph 1, Ph 2 | terminated | A Study to Characterize the Pharmacokinetics and Tolerability of Buprenorphine Patches in Children With Moderate to Severe Mouth Pain |
| NCT02176291 IRLGREY-B results posted | PRO13120236 R34MH101371 | Ph 2 | completed | Incomplete Response in Late-Life Depression: Getting to Remission With Buprenorphine |
| NCT01708707 | Banner IRB 01-13-0030 | Ph 2 | completed | Comparison of Buprenorphine to Morphine in Treatment of Neonatal Abstinence Syndrome (NAS) |
| NCT02263248 (IRLGREY-B) | 035/2014 | Ph 1, Ph 2 | completed | Incomplete Response in Late-Life Depression: Getting to Remission With Buprenorphine |
| NCT01377610 | #6374/7250R 2R01DA010746-09A1 | Ph 1 | completed | Improved Strategies for Outpatient Opioid Detoxification |
| NCT02044094 results posted | RB-US-13-0002 | Ph 2 | completed | Multiple Dose Study of Blockade of Opioid Effects by Injections of Buprenorphine in Participants With Opioid Disorder |
| NCT01071538 BUILD results posted | BUILD KL2RR024154 | Ph 2 | completed | Buprenorphine for Late-Life Treatment Resistant Depression |
| NCT01407575 BUP-TRD results posted | BUP-TRD | Ph 3 | completed | Buprenorphine for Treatment Resistant Depression |
| NCT01561079 results posted | 00051600 | Ph 2, Ph 3 | completed | Fetal and Infant Effects of Maternal Buprenorphine Treatment |
| NCT02372591 1401 | NA_00093537 K23DA029609 | Ph 1 | completed | Study of the Treatment of Experimental Pain in Buprenorphine Maintained Persons With Chronic Musculoskeletal Pain |
| NCT01642030 | NA_00071459 K23DA029609, 1203 | Ph 1 | completed | Study of the Treatment of Experimental Pain in Opioid Dependent Persons on Methadone or Buprenorphine Maintenance |
| NCT02634788 results posted | INS005-15-062 | Ph 3 | completed | Study of Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain |
| NCT02198235 results posted | 2012-017 | Ph 1 | completed | Prolonged Popliteal Fossa Nerve Blockade (Prolonged Pop) |
| NCT03174067 BED | BED2013 | Ph 4 | completed | Buprenorphine in the Emergency Department |
Showing 50 of 81 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BUTRANS FDA Label Details
Indications & Usage
FDA Label (PDF)BUTRANS is indicated for the treatment of Pain.
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUTRANS Addiction, Abuse, and Misuse Because the use of BUTRANS ® exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and re...
Track BUTRANS with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.