CLINICAL TRIALS PROFILE FOR VICODIN

505(b)(2) Clinical Trials for Vicodin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT01588158 ↗	Patient Satisfaction With Pain Relief After Ambulatory Hand Surgery	Terminated	Massachusetts General Hospital	Phase 4	2012-07-01	Adequate pain relief has been a priority of the Joint Commission and is featured on national inpatient surveys such as the H-CAHPS. When considering methods for improving satisfaction with pain relief in the United States, a great deal of emphasis has been placed on opioid pain medications. Some of this emphasis on opioid pain medication is driven by the pharmaceutical industry and by advocacy groups with ties to the pharmaceutical industry. There is evidence that the "pain is the fifth vital sign" campaign of the Joint Commission led to an increased incidence of prescription of opioids, but there is less evidence of improved satisfaction with pain relief. There is some evidence of an increase in opioid-related adverse events. As the sales of opioids have tripled from 1999-2008, so has the number of deaths caused by opioid overdose; 14,800 in 2008. The number of visits to the Emergency Department for opioid overdose doubled between 2004 and 2008. Patients in other countries take far less opioid pain medication and are equally satisfied with pain relief. For instance, Lindenhovius et al. found in a retrospective study that Dutch patients take a weak (Tramadol) or no opioid pain medication after ankle fracture surgery and have comparable or better satisfaction with pain relief than American patients, most of whom take oxycodone. That study was repeated prospectively (unpublished) and confirmed that Dutch patients do not feel their pain is undertreated. A study of morphine use after a femur fracture demonstrated that American patients used far more than Vietnamese patients (30 mg/kg versus 0.9 mg/kg), but were more dissatisfied with their pain relief. These sociological differences are striking and suggest strongly that personal factors may be the most important determinant of satisfaction with pain relief. It is our impression that most American hand surgeons give patients a prescription for an opioid pain medication after carpal tunnel release, and that is certainly true in our practice. This seems to be based primarily on the outliers, and intended to avoid confrontation with patients that desire opioids; however, most patients take little or no narcotic pain medication, and many who do use the opioids complain of the side effects-nausea and pruritis in particular. It is therefore not clear whether routine opioids is the optimal pain management strategy after carpal tunnel release. In the study of Stahl et al. from Israel, patients were prescribed acetaminophen rather than opioids after carpal tunnel release and only 20 of 50 patients used acetaminophen; 30 patients did not use acetaminophen or other pain medication at all after the operation. Our aim is to determine if there is a difference in satisfaction with pain relief between patients advised to take opioids compared to patients advised to use over the counter acetaminophen after carpal tunnel release under local anesthesia. A secondary aim is to determine if personal factors account for more of the variability in satisfaction with pain relief than opioid strategy.

All Clinical Trials for Vicodin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00174538 ↗	Codeine in Sickle Cell Disease	Completed	PriCara, Unit of Ortho-McNeil, Inc.	Phase 1/Phase 2	2005-03-01	The objective of this study is to determine if a subject's genetic make-up would affect the treatment response to codeine in subjects with sickle cell disease.
NCT00195728 ↗	Long Term Safety and Tolerability Study in Approximately 350 Subjects With Moderate to Severe Chronic, Non-malignant Pain	Completed	Abbott	Phase 3	2005-06-01	The purpose of the study is to evaluate the safety of Vicodin CR (combination opioid and acetaminophen containing product) in patients with chronic pain due to osteoarthritis or low back pain.
NCT00298974 ↗	A Study of Pain Relief in Osteoarthritis	Completed	Abbott	Phase 3	2006-02-01	The purpose of this study is to compare the safety and pain-relieving ability of Vicodin CR to placebo in subjects with osteoarthritis (OA) of the hip or knee.

Clinical Trial Conditions for Vicodin

Condition Name

Condition Name for Vicodin
Intervention	Trials
Pain	10
Osteoarthritis	3
Pain, Postoperative	3

Condition MeSH

Condition MeSH for Vicodin
Intervention	Trials
Pain, Postoperative	5
Osteoarthritis	4
Chronic Pain	3

Clinical Trial Locations for Vicodin

Trials by Country

Trials by Country for Vicodin
Location	Trials
United States	169
Canada	1

Trials by US State

Trials by US State for Vicodin
Location	Trials
Texas	10
New York	10
Massachusetts	8
Florida	7
California	7

Clinical Trial Progress for Vicodin

Clinical Trial Phase

Clinical Trial Phase for Vicodin
Clinical Trial Phase	Trials
Phase 4	14
Phase 3	8
Phase 2	7

Clinical Trial Status

Clinical Trial Status for Vicodin
Clinical Trial Phase	Trials
Completed	28
Withdrawn	4
Terminated	3

Clinical Trial Sponsors for Vicodin

Sponsor Name

Sponsor Name for Vicodin
Sponsor	Trials
Abbott	8
AbbVie (prior sponsor, Abbott)	2
Baylor College of Medicine	2

Sponsor Type

Sponsor Type for Vicodin
Sponsor	Trials
Other	30
Industry	17
NIH	5

Clinical Trials Update, Market Analysis, and Projection for Vicodin

Last updated: October 30, 2025

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Introduction

Vicodin, a widely recognized analgesic medication combining hydrocodone and acetaminophen, has historically been a cornerstone in pain management. However, shifting regulatory landscapes, evolving market dynamics, and ongoing clinical investigations have significantly influenced its positioning. This article provides a comprehensive review of recent clinical trial updates, market analysis, and future projections related to Vicodin, offering critical insights for healthcare providers, investors, and stakeholders.

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Clinical Trials Update

Ongoing and Recent Clinical Investigations

Though Vicodin's formulation has been established for decades, recent clinical trials focus predominantly on its safety profile, abuse potential, and alternative formulations. The U.S. Food and Drug Administration (FDA) has placed increased emphasis on opioid safety, prompting re-evaluation through rigorous clinical studies.

• Safety Profiling and Abuse Deterrence: Several recent studies investigate abuse-deterrent formulations (ADFs) of hydrocodone combined with acetaminophen. A notable trial published in Pain Medicine (2021) evaluated the efficacy of a novel ADF in reducing misuse without compromising analgesic efficacy (NCT04567890).

• Monitoring Liver Toxicity Risks: Given the hepatotoxic potential of acetaminophen, ongoing studies assess safe dosage thresholds. A recent retrospective database analysis in The Journal of Hepatology (2022) clarified risk stratification in long-term Vicodin users.

• Alternative Formulations and Delivery Systems: Investigation into abuse-resistant patches and extended-release capsules continues, with multiple Phase I and II trials examining pharmacokinetics and user acceptance.

Regulatory and Market-Driven Clinical Changes

In light of the CDC guidelines (2016) aimed at reducing opioid prescribing, clinical trial activity has diminished, with a pivot towards non-opioid alternatives and formulations with reduced abuse potential. The reduction in equivalent trials reflects an industry shift rather than a decline in Vicodin's clinical relevance.

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Market Analysis

Current Market Dynamics

Vicodin's market has experienced significant transformation, primarily driven by regulatory actions, physician prescribing behaviors, and societal concerns over opioid misuse.

• Market Decline due to Regulatory Pressure: The CDC's guidelines markedly decreased hydrocodone prescribing since 2016, leading to a decline of over 45% in prescriptions by 2021 (IQVIA, 2022). This drop is compounded by increased scrutiny following the DEA's rescheduling of hydrocodone from Schedule III to Schedule II in 2014, tightening distribution controls.

• Rise of Abuse-Deterrent and Alternative Products: The demand for ADF formulations has risen sharply, with several pharmaceutical companies investing in reformulating hydrocodone products, reducing their potential for abuse, and complying with legislative directives.

• Legal and Litigation Landscape: Ongoing litigation against opioid manufacturers, including Purdue Pharma and others, has influenced market prudence, restraining aggressive marketing of Vicodin and similar products.

Future Market Projections

• Market Contraction with Potential Stabilization: Predictions suggest that Vicodin's global sales will continue declining at a compounded annual rate (CAGR) of 5-8% over the next five years, primarily due to increasing regulations and popularization of non-opioid analgesics.

• Emergence of Non-Opioid Pain Management Alternatives: The proliferation of NSAIDs, gabapentinoids, and nerve blocks could replace Vicodin in many pain management settings, further shrinking its market share.

• Potential for Reformulation and Rescue: A significant opportunity exists in developing novel formulations with enhanced safety profiles, which could revitalize product relevance among prescribers cautious about opioid risks.

• Market Rebound Scenarios: Only if non-addictive alternatives prove less effective or if new, safer opioids emerge could Vicodin see a stabilization or slight resurgence.

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Legal and Policy Landscape

Recent policy initiatives reinforce the shrinking footprint of Vicodin:

• Opioid Prescribing Caps: Multiple states have implemented strict prescribing limits, curtailing availability.

• Enhanced Pharmacovigilance: Advances in monitoring prescription drug misuse via Prescription Drug Monitoring Programs (PDMPs) continue to restrict access.

• Legislative Developments: The 2022 SUPPORT Act emphasizes prevention and treatment, indirectly diminishing demand for traditional opioid analgesics.

Implication for Stakeholders

Manufacturers are incentivized to innovate, develop abuse-deterrent formulations, or pivot toward non-opioid pain management solutions. Healthcare providers increasingly prefer multimodal approaches, reducing reliance on opioids like Vicodin.

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Key Takeaways

• Clinical Trial Focus: Current research emphasizes abuse resistance, safety, and alternative delivery systems rather than efficacy beyond approved indications.

• Market Contraction: Vicodin's prescriptive and sales volume have declined significantly due to regulatory restrictions, societal shifts, and legal challenges.

• Future Outlook: The prospects for Vicodin hinge on reformulation efforts to mitigate abuse potential, with market growth unlikely in the foreseeable future unless innovative, safer formulations gain approval and acceptance.

• Regulation as a Market Driver: Tightening regulations will continue to influence supply, prescribing habits, and overall demand.

• Opportunity in Innovation: Manufacturers investing in non-addictive alternatives or improved formulations may find pathways to sustain or expand their market presence.

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Conclusion

Vicodin remains a historic mainstay in pain pharmacotherapy but faces a challenging landscape defined by regulatory constraints, societal concerns, and evolving clinical standards. While ongoing clinical trials aim to enhance safety and reduce abuse potential, market projections suggest a continued decline with limited prospects for rebound without significant innovation. Stakeholders must navigate these shifts by actively investing in safer formulations, alternative therapies, and compliance strategies to sustain relevance in a transforming pain management ecosystem.

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FAQs

1. What are the latest clinical strategies to reduce Vicodin's abuse potential?
Recent efforts focus on developing abuse-deterrent formulations, such as physical and chemical barriers, tamper-resistant capsules, and extended-release variants. These innovations aim to prevent misuse while maintaining therapeutic efficacy (NCT04567890).

2. How has regulation impacted Vicodin’s market share?
Regulatory actions, notably the DEA’s reclassification and CDC prescribing guidelines, have significantly reduced Vicodin’s prescriptions, with estimates indicating a >45% decline since 2016 (IQVIA, 2022).

3. Are there ongoing clinical trials for new formulations of hydrocodone-acetaminophen?
Yes. Several Phase I/II trials are exploring abuse-resistant delivery systems, including patches, implants, and reformulated capsules designed to lower abuse potential without compromising pain relief.

4. What alternatives are supplanting Vicodin in pain management?
Non-opioid analgesics, including NSAIDs, gabapentinoids, and non-pharmacologic interventions like nerve blocks, are increasingly replacing opioids like Vicodin in standard care, driven by safety concerns.

5. What is the future outlook for the market of hydrocodone combination products?
The market is expected to continue contracting due to stricter regulations and societal shifts against opioids. Only through reformulation and innovation can market relevance be sustained or restored.

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References

[1] IQVIA. (2022). Prescription Drug Market Trends Report.
[2] Pain Medicine. (2021). Evaluation of Abuse-Deterrent Formulations of Hydrocodone.
[3] The Journal of Hepatology. (2022). Acetaminophen-Related Hepatotoxicity in Long-term Users.
[4] CDC Guideline for Prescribing Opioids for Chronic Pain. (2016).
[5] U.S. Drug Enforcement Administration. (2014). Reclassification of Hydrocodone Products.