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opioid free anesthesia
opioid free anesthesia is a local anesthetic Small molecule drug developed by Peking University People's Hospital. It is currently in Phase 3 development for General anesthesia for surgical procedures. Also known as: opioid free, OFA.
opioid-free anesthesia works by using a combination of local anesthetics and adjuvants to provide pain relief without the use of opioids.
Opioid-free anesthesia (OFA) is a type of anesthesia that does not involve opioids, and it has been studied in various conditions, including postoperative nausea and vomiting, opioid use, and implicit memorization. The exact mechanism of OFA is currently unknown, but it has been investigated as an alternative to traditional opioid-based anesthesia in clinical trials, such as the "Dreams or Implicite Memorization Under OFA" study.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | opioid free anesthesia |
|---|---|
| Also known as | opioid free, OFA |
| Sponsor | Peking University People's Hospital |
| Drug class | local anesthetic |
| Modality | Small molecule |
| Therapeutic area | Anesthesiology |
| Phase | Phase 3 |
Mechanism of action
opioid-free anesthesia typically involves the use of local anesthetics such as lidocaine or ropivacaine, combined with adjuvants like clonidine or ketamine to enhance analgesia and reduce the need for opioids. This approach can help reduce the risk of opioid-related side effects and promote a faster recovery.
Approved indications
- General anesthesia for surgical procedures
Common side effects
- Nausea
- Vomiting
- Dizziness
Key clinical trials
- The Relationship Between Opioid-Free Anesthesia and Postoperative Agitation-Delirium and Quality of Recovery in Pediatric Ear, Nose, and Throat Cases Monitored With Perioperative Bispectral Index
- Opioid Free and Opioid Based Anesthesia in Elective Lumbar Spine Surgery
- Cardiac Index and General Anesthesia Without Opioid. (PHASE2, PHASE3)
- Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy (PHASE2, PHASE3)
- Opioid-Free vs Opioid-Based Anesthesia in Bariatric Surgery (NA)
- Postoperative Analgesic Efficacy of SPSIPB in Anterior Cervical Discectomy (NA)
- Transition From Acute to Chronic Opioid Use and Chronic Pain (EARLY_PHASE1)
- LIdocaine veRsus Sufentanil Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass
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:
- opioid free anesthesia CI brief — competitive landscape report
- opioid free anesthesia updates RSS · CI watch RSS
- Peking University People's Hospital portfolio CI
Frequently asked questions about opioid free anesthesia
What is opioid free anesthesia?
How does opioid free anesthesia work?
What is opioid free anesthesia used for?
Who makes opioid free anesthesia?
Is opioid free anesthesia also known as anything else?
What drug class is opioid free anesthesia in?
What development phase is opioid free anesthesia in?
What are the side effects of opioid free anesthesia?
Related
- Drug class: All local anesthetic drugs
- Manufacturer: Peking University People's Hospital — full pipeline
- Therapeutic area: All drugs in Anesthesiology
- Indication: Drugs for General anesthesia for surgical procedures
- Also known as: opioid free, OFA
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing