NDATRANSDERMALFILM, EXTENDED RELEASE
Approved
Jun 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
6/8 — Strong
BUTRANS (buprenorphine) by Purdue Pharma is partial opioid agonists [moa]. Approved for opioid use disorder, chronic pain. First approved in 2010.
Drug data last refreshed 22h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BUTRANS is a transdermal extended-release film formulation of buprenorphine, a partial opioid agonist approved by the FDA in June 2010 for the management of severe, persistent pain in patients requiring opioid analgesia. Unlike full opioid agonists, buprenorphine's partial agonist mechanism provides a ceiling effect on respiratory depression, potentially offering a safer opioid profile. The product is positioned as an alternative to immediate-release opioids for chronic pain management in opioid-tolerant patients.
$0.0BPart D
Mechanism of Action
Partial Opioid Agonists
Pharmacologic Class:
Partial Opioid Agonist
Indications (2)
Clinical Trials (20)
Acceptability and Feasibility of Extended-Release Subcutaneous Buprenorphine on a Mobile Pharmacy Clinic
Started Apr 2026
60 enrolled
Opioid Use Disorder
Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder
Started Dec 2025
A Study to Test Whether BI 1356225 Improves Impulsive Behavior in People With Opioid Use Disorder Who Are Taking Buprenorphine
Started Jan 2025
60 enrolled
Opioid Use Disorder
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
Started Jan 2025
32 enrolled
Healthy Volunteer Study
An Exploratory Clinical Study of a Low-dose Buprenorphine Patch for the Treatment of Autism Spectrum Disorders
Started Jan 2025
60 enrolled
Autism Spectrum Disorder
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.