BUPRENORPHINE
Details
- Status
- Prescription
- First Approved
- 2018-11-20
- Routes
- TRANSDERMAL
- Dosage Forms
- FILM, EXTENDED RELEASE
BUPRENORPHINE Approval History
What BUPRENORPHINE Treats
1 indicationsBUPRENORPHINE is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
BUPRENORPHINE Boxed Warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUPRENORPHINE TRANSDERMAL SYSTEM Addiction, Abuse, and Misuse Because the use of buprenorphine transdermal system 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 Depressi...
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUPRENORPHINE TRANSDERMAL SYSTEM Addiction, Abuse, and Misuse Because the use of buprenorphine transdermal system 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 buprenorphine transdermal system, especially during initiation or following a dosage increase . To reduce the risk of respiratory depression, proper dosing and titration of buprenorphine transdermal system are essential. Misuse or abuse of buprenorphine transdermal system 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 buprenorphine transdermal system, 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 buprenorphine transdermal system 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) If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, wh
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Active Pipeline
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Key Completed Trials
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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.
BUPRENORPHINE FDA Label Details
ProIndications & Usage
Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse and misuse with opioids, which can occur at any dosage or duration, and because of the greater risk of overdose and death with extended-release/long acting opioid formulations [see Warnings and Precautions ] , reserve buprenorphine transdermal system for use in patients for whom alternative treatment options (e...
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUPRENORPHINE TRANSDERMAL SYSTEM Addiction, Abuse, and Misuse Because the use of buprenorphine transdermal system exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.