Last reviewed · How we verify
Placebo oxycodone/acetaminophen tablets
Placebo oxycodone/acetaminophen tablets is a Small molecule drug developed by Purdue Pharma LP. It is currently in Phase 3 development for Control arm in clinical trials for opioid/acetaminophen combination pain relief.
This is a placebo formulation containing no active pharmaceutical ingredients, used as a control in clinical trials to establish the true efficacy of oxycodone/acetaminophen combination therapy.
This is a placebo formulation containing no active pharmaceutical ingredients, used as a control in clinical trials to establish the true efficacy of oxycodone/acetaminophen combination therapy. Used for Control arm in clinical trials for opioid/acetaminophen combination pain relief.
-
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 | Placebo oxycodone/acetaminophen tablets |
|---|---|
| Sponsor | Purdue Pharma LP |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
Placebo tablets are inert formulations designed to match the appearance and administration route of the active drug being tested. In Phase 3 trials, placebos serve as the control arm to distinguish genuine pharmacological effects of oxycodone (an opioid analgesic) and acetaminophen (an analgesic/antipyretic) from placebo response and natural disease progression.
Approved indications
- Control arm in clinical trials for opioid/acetaminophen combination pain relief
Common side effects
Key clinical trials
- Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis (NA)
- Opioid-Sparing Joint Replacement (PHASE3)
- Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure (PHASE2)
- Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy (PHASE3)
- Are Opioids Needed After ACL Reconstruction (PHASE4)
- A Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg for Acute Pain and the Prevention of OINV (PHASE3)
- Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study (PHASE2)
- Study to Collect Information on How Well the Study Drug Naproxen Sodium Tablets Works Compared to Hydrocodone/Acetaminophen Tablets in Order to Relieve Pain in Participants Experiencing Moderate to Severe Pain After Having Their Wisdom Teeth Removed (PHASE4)
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:
- Placebo oxycodone/acetaminophen tablets CI brief — competitive landscape report
- Placebo oxycodone/acetaminophen tablets updates RSS · CI watch RSS
- Purdue Pharma LP portfolio CI
Frequently asked questions about Placebo oxycodone/acetaminophen tablets
What is Placebo oxycodone/acetaminophen tablets?
How does Placebo oxycodone/acetaminophen tablets work?
What is Placebo oxycodone/acetaminophen tablets used for?
Who makes Placebo oxycodone/acetaminophen tablets?
What development phase is Placebo oxycodone/acetaminophen tablets in?
Related
- Manufacturer: Purdue Pharma LP — full pipeline
- Therapeutic area: All drugs in Pain Management
- Indication: Drugs for Control arm in clinical trials for opioid/acetaminophen combination pain relief
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing