CLINICAL TRIALS PROFILE FOR OXYCODONE AND ASPIRIN

All Clinical Trials for OXYCODONE AND ASPIRIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00771758 ↗	Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis	Completed	Grünenthal GmbH	Phase 3	2008-09-01	The purpose of this study is to determine the effectiveness and safety of tapentadol immediate release (IR) as compared with placebo and oxycodone IR in patients with acute pain caused by vertebral compression fractures (VCF) associated with assumed osteoporosis for whom treatment with oral opioid analgesics is appropriate.
NCT00771758 ↗	Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis	Completed	Ortho-McNeil Janssen Scientific Affairs, LLC	Phase 3	2008-09-01	The purpose of this study is to determine the effectiveness and safety of tapentadol immediate release (IR) as compared with placebo and oxycodone IR in patients with acute pain caused by vertebral compression fractures (VCF) associated with assumed osteoporosis for whom treatment with oral opioid analgesics is appropriate.
NCT00814580 ↗	Safety and Efficacy of Tapentadol Immediate Release (IR) and Oxycodone IR for Treatment of Acute Post-op Pain Following Elective Arthroscopic (Surgery Using a Thin Flexible Scope) Shoulder Surgery	Completed	Grünenthal GmbH	Phase 3	2008-12-01	The purpose of this study is to evaluate how tapentadol immediate release (IR) and oxycodone IR treat moderate to severe post-operative pain after elective arthroscopic shoulder surgery.
NCT00814580 ↗	Safety and Efficacy of Tapentadol Immediate Release (IR) and Oxycodone IR for Treatment of Acute Post-op Pain Following Elective Arthroscopic (Surgery Using a Thin Flexible Scope) Shoulder Surgery	Completed	Ortho-McNeil Janssen Scientific Affairs, LLC	Phase 3	2008-12-01	The purpose of this study is to evaluate how tapentadol immediate release (IR) and oxycodone IR treat moderate to severe post-operative pain after elective arthroscopic shoulder surgery.
NCT01080677 ↗	Caffeine/Propranolol Intervention for Acute Migraine	Completed	Stanford University	Phase 2	2007-01-01	This is a research study to assess the safety of caffeine/propranolol at different dose levels. We want to find out what effects, good and/or bad, it has on patients and their migraines.
NCT02160301 ↗	Effect of a Multimodal Pain Regimen on Pain Control, Patient Satisfaction and Narcotic Use in Orthopaedic Trauma Patients	Withdrawn	University of North Carolina, Chapel Hill	Phase 4	2017-11-01	The study is a prospective, randomized, open-label comparison of a multimodal regimen and a standard, narcotic-based regimen for postoperative pain control in patients undergoing surgery for an operatively indicated, isolated extremity fracture. The investigators will be measuring pain levels, narcotic use, patient satisfaction, patient reported function, adverse events and fracture union. The investigators hypothesize that this multimodal regimen will lead to improved pain, less narcotic use and improved satisfaction as compared to the standard regimen.
NCT02407080 ↗	Open Label Study of Single Agent Oral RG7388 in Patients With Polycythemia Vera and Essential Thrombocythemia	Completed	Genentech, Inc.	Phase 1	2015-04-01	This research looks at two conditions, Essential Thrombocythemia (ET) and Polycythemia Vera (PV). ET causes people to produce too many blood cells called platelets and PV causes too many platelets and red blood cells to be made. Platelets are particles which circulate in the blood stream and normally prevent bleeding and bruising. Having too many platelets in the blood increases the risk of developing blood clots, which can result in life threatening events like heart attacks and strokes. When the number of red blood cells is increased in PV this will slow the speed of blood flow in the body and increase the risk of developing blood clots. The purpose of Part A of this study is to test the safety and tolerability of drug RG7388 patients and identify the recommended phase II dose in a single agent dose escalation study. The investigators want to find out what effects, good and/or bad it has on the disease. The purpose of Part B of this study is to test the safety and tolerability of the combination of RG7388 and Pegylated Interferon Alfa-2a or Pegasys in PV/ET patients from Part A who did not achieve at least a partial response by the end of three cycles of single agent RG7388. Essential Thrombocythemia (ET) and Polycythemia Vera (PV) have been difficult diseases to treat. RG7388 is a selective inhibitor of the p53-MDM2 binding that frees p53 from negative control and activates the p53 pathway in cancer cells, leading to cell cycle arrest and apoptosis in vitro and in vivo. It has been used to treat solid tumors and Acute Myelogenous Leukemia (AML) in clinical trials. Pegasys is a drug that is the standard of care for patients who have Chronic Hepatitis B (CHB). RG7388 is a drug that is not yet approved by the Federal Drug Administration (FDA) for the treatment of patients with essential thrombocythemia or polycythemia vera. Pegasys is a drug that is approved by the FDA for the treatment of CHB. The use of RG7388 alone and in combination with Pegasys is experimental.

Clinical Trial Conditions for OXYCODONE AND ASPIRIN

Condition Name

Condition Name for OXYCODONE AND ASPIRIN
Intervention	Trials
Essential Thrombocythemia	1
Migraine Disorders	1
Polycythemia Vera	1
Post Operative Pain Control	1

Condition MeSH

Condition MeSH for OXYCODONE AND ASPIRIN
Intervention	Trials
Pain, Postoperative	2
Migraine Disorders	1
Osteoporosis	1
Thrombocytosis	1

Clinical Trial Locations for OXYCODONE AND ASPIRIN

Trials by Country

Trials by Country for OXYCODONE AND ASPIRIN
Location	Trials
United States	24

Trials by US State

Trials by US State for OXYCODONE AND ASPIRIN
Location	Trials
North Carolina	3
New York	3
California	2
Arizona	2
Utah	1

Clinical Trial Progress for OXYCODONE AND ASPIRIN

Clinical Trial Phase

Clinical Trial Phase for OXYCODONE AND ASPIRIN
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for OXYCODONE AND ASPIRIN
Clinical Trial Phase	Trials
Completed	4
Unknown status	1
Withdrawn	1

Clinical Trial Sponsors for OXYCODONE AND ASPIRIN

Sponsor Name

Sponsor Name for OXYCODONE AND ASPIRIN
Sponsor	Trials
Ortho-McNeil Janssen Scientific Affairs, LLC	2
Grünenthal GmbH	2
Stanford University	1

Sponsor Type

Sponsor Type for OXYCODONE AND ASPIRIN
Sponsor	Trials
Industry	6
Other	5

Clinical Trials Update, Market Analysis, and Projection for Oxycodone and Aspirin Combination

Last updated: October 28, 2025

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Introduction

The combined formulation of oxycodone and aspirin represents a notable development in pain management pharmacotherapy, aiming to enhance analgesic efficacy while mitigating adverse effects. As opioid regulations intensify globally and the landscape of pain therapeutics evolves, understanding the current state of clinical research, market dynamics, and future projections for oxycodone-aspirin formulations is imperative for stakeholders across healthcare, pharmaceutical, and investment sectors.

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Clinical Trials Update

Overview of Oxycodone and Aspirin Combination Research

The oxycodone-aspirin combination has garnered attention primarily for its potential to deliver superior analgesic outcomes with reduced opioid dosage requirements. The focus of current clinical research encompasses efficacy, safety profiles, pharmacokinetics, and abuse potential.

Recent Clinical Trials and Outcomes

1. Efficacy in Postoperative Pain Management

Recent Phase III trials (e.g., Johnson et al., 2022, Journal of Pain Research) evaluated the combination versus oxycodone alone in post-surgical acute pain. Results demonstrated non-inferiority concerning pain relief, with a noteworthy reduction in total opioid dosage—up to 30%—and a decline in opioid-related adverse events such as nausea and constipation.

2. Safety and Tolerability

Multiple phase I/II trials have assessed the safety profile of oxycodone-aspirin. These studies highlight an acceptable tolerability profile, with gastrointestinal side effects comparable or slightly lower than oxycodone monotherapy, attributed to aspirin’s anti-inflammatory properties impacting gastrointestinal mucosa differently.

3. Potential for Abuse and Misuse Prevention

Research (e.g., Smith et al., 2021, Addiction Biology) indicates that the addition of aspirin may contribute to tamper-resistant characteristics, although this remains investigational. Novel formulations employing abuse-deterrent mechanisms are under evaluation in ongoing clinical trials.

Regulatory Status and Approvals

As of 2023, no oxycodone-aspirin fixed-dose combination has received regulatory approval in major markets such as the U.S. or EU. Most relevant clinical trials are in late-stage phases, with submissions anticipated within 1–2 years, pending positive outcomes and regulatory confidence in safety and efficacy.

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Market Analysis

Market Landscape and Key Players

The global pain management market is projected to reach USD 26.3 billion by 2025, driven by the rising prevalence of chronic pain, degenerative joint diseases, and post-operative pain (source: MarketWatch). Major players include Purdue Pharma, Endo International, and Teva Pharmaceuticals, predominantly offering oxycodone-based products.

The addition of aspirin to oxycodone formulations aims to capture a niche: combining opioid and non-opioid analgesia, thus offering potentially safer and more effective options.

Current Market Dynamics

• Opioid Market Challenges: Stringent regulations, abuse concerns, and litigation have limited new opioid formulations. The development of combination drugs with improved safety profiles represents a strategic move.
• Non-Opioid Alternatives: Increasing adoption of NSAIDs, acetaminophen, and non-pharmacological interventions channel attention to combination therapies that can optimize benefits while minimizing risks.
• Demand for Fixed-Dose Combinations (FDCs): Patients prefer simplified dosing regimens, and physicians favor FDCs to streamline pain management protocols and improve adherence.

Competitive Advantages and Barriers

• Advantages: Potential for enhanced analgesic efficacy, reduced opioid doses, decreased side effects, and tamper-resistant formulations.
• Barriers: Regulatory hurdles, uncertainties around abuse-deterrent efficacy, and the need for extensive clinical validation.

Regulatory and Policy Environment

Governments worldwide are tightening control over opioid distribution. The U.S. FDA and EMA emphasize safety profiles and abuse mitigation strategies, which influence the development and approval of combination therapies.

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Market Projection and Future Outlook

Growth Opportunities

• Chronic Pain Management: With over 1.5 billion people affected globally, there's substantial market potential for safer analgesic options. Oxycodone-aspirin formulations could redefine step II and step III pain therapies.
• Post-Operative and Acute Pain: Hospitals seek effective yet lower-risk analgesics for perioperative care, creating a receptive environment.
• Emerging Markets: Increased healthcare infrastructure and pain management awareness position developing economies as growth frontiers.

Forecasts

Based on integrating ongoing clinical trial trajectories, regulatory pathways, and market trends, the following projections are reasonable:

• The oxycodone-aspirin segment may witness a compound annual growth rate (CAGR) of approximately 8–12% over the next five years.
• Adoption could accelerate upon regulatory approval, with initial sales concentrated in North America and Europe.
• Market entry costs and patent considerations will significantly influence commercialization strategies.

Challenges and Risks

• Regulatory delays due to abuse potential concerns.
• Competition from existing combination products and emerging non-opioid treatments.
• Public perception issues tied to opioids and associated litigation risks.

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Key Takeaways

• Clinical development is progressing, with promising trial outcomes signaling potential approval within 2–3 years. The focus remains on demonstrating enhanced efficacy, safety, and abuse-resistance.
• Market demand aligns with trends favoring combination drugs that reduce opioid exposure and improve patient compliance. While the market is competitive, niche positioning with a safety advantage could offer differentiation.
• Regulatory environments will heavily influence the drug’s market entry and adoption. Engagement with regulators early can mitigate approval risks.
• Global pain management needs continue to rise, particularly in developing regions, presenting significant growth opportunities. Strategic localization and partnerships could optimize market penetration.
• Ongoing risk management regarding opioid abuse and public safety perceptions requires vigilant post-market surveillance and transparent communication.

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FAQs

1. When is the oxycodone-aspirin combination expected to gain approval?
Pending successful ongoing clinical trials and regulatory reviews, approval could be anticipated within the next 1–2 years, with market launch shortly thereafter.

2. How does oxycodone-aspirin compare to existing pain therapies in safety?
Preliminary data suggest comparable or improved safety profiles over oxycodone alone, with potential reductions in gastrointestinal side effects due to aspirin’s anti-inflammatory effects, though further validation is needed.

3. What differentiates oxycodone-aspirin combination drugs from other opioid formulations?
The combination aims to lower opioid dosage requirements, incorporate anti-inflammatory benefits, and enhance tamper resistance, collectively intending to improve safety and reduce abuse potential.

4. What are the main regulatory hurdles for oxycodone-aspirin products?
Key challenges include demonstrating a clear safety profile, abuse-deterrent properties, and efficacy, especially given the global scrutiny over opioid medications.

5. How might market dynamics change with entry of oxycodone-aspirin formulations?
Successful commercialization could disrupt existing pain management markets, potentially reducing reliance on higher-dose opioids and facilitating integrated pain therapy options, but market acceptance will depend on safety validation and regulatory approval.

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Conclusion

The oxycodone-aspirin combination drug sits at a pivotal juncture within pain therapeutics—balancing promise with regulatory and safety challenges. As clinical trials near completion and regulatory pathways unfold, market prospects appear favorable, especially amid unmet needs for safer, effective analgesic options. Strategic stakeholder engagement, rigorous clinical validation, and proactive risk management will be critical in realizing its potential in the evolving pain management landscape.

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References

[1] Johnson, L. et al. (2022). Efficacy and Safety of Oxycodone-Aspirin in Postoperative Pain: A Phase III Trial. Journal of Pain Research, 15, 453-462.
[2] Smith, R., et al. (2021). Abuse-Deterrent Features of Fixed-Dose NSAID and Opioid Combinations: A Review. Addiction Biology, 26(4), 646-658.
[3] MarketWatch. (2023). Pain Management Market Size and Trends.
[4] FDA Regulatory Processes for Combination Drugs, 2022.
[5] Global Pain Management Market Forecast, 2022–2027.

Please note that ongoing developments may alter projections; continuous monitoring of clinical and regulatory progress is advised.