Last reviewed · How we verify
Buprenorphine transdermal delivery system
Buprenorphine is a partial mu-opioid receptor agonist that binds with high affinity to opioid receptors in the central nervous system to produce analgesia and reduce opioid cravings.
Buprenorphine is a partial mu-opioid receptor agonist that binds with high affinity to opioid receptors in the central nervous system to produce analgesia and reduce opioid cravings. Used for Moderate to severe chronic pain, Opioid use disorder (maintenance treatment).
At a glance
| Generic name | Buprenorphine transdermal delivery system |
|---|---|
| Sponsor | Purdue Pharma LP |
| Drug class | Partial mu-opioid receptor agonist |
| Target | Mu-opioid receptor (μ-OR) |
| Modality | Small molecule |
| Therapeutic area | Pain Management; Opioid Use Disorder |
| Phase | Phase 3 |
Mechanism of action
Buprenorphine's partial agonist activity at the mu-opioid receptor provides a ceiling effect on respiratory depression, making it safer than full opioid agonists. The transdermal delivery system provides sustained, controlled release of the drug through the skin, enabling prolonged therapeutic effect with reduced dosing frequency compared to oral or sublingual formulations.
Approved indications
- Moderate to severe chronic pain
- Opioid use disorder (maintenance treatment)
Common side effects
- Application site reactions (erythema, pruritus)
- Headache
- Nausea
- Dizziness
- Constipation
- Somnolence
Key clinical trials
- Butrans for Treatment of Restless Legs Syndrome (PHASE4)
- The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) at Doses up to 80 Micrograms/Hour (mcg/hr) and Naltrexone on Electrocardiogram (ECG) Intervals in Healthy Volunteers (PHASE1)
- An Assessment of Buprenorphine Transdermal Delivery System (BTDS) Patch Adhesion (PHASE1)
- A Dose Proportionality and Bioavailability Assessment of Buprenorphine Transdermal Delivery System Second Generation Patches (PHASE1)
- The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Low Back Pain. (PHASE3)
- Safety of Buprenorphine Transdermal Systems in Subjects With Chronic Nonmalignant Pain - a 28-week Extension Study (PHASE3)
- The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) on QT Intervals in Healthy Volunteers (PHASE1)
- Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Buprenorphine transdermal delivery system CI brief — competitive landscape report
- Buprenorphine transdermal delivery system updates RSS · CI watch RSS
- Purdue Pharma LP portfolio CI