CLINICAL TRIALS PROFILE FOR VICODIN ES

505(b)(2) Clinical Trials for Vicodin Es

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 That study was repeated prospectively (unpublished) and confirmed that Dutch patients do not feel their pain is undertreated.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 Es

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.
NCT00304317 ↗	Celecoxib (Celebrex) in the Management of Acute Renal Colic	Withdrawn	Pfizer	Phase 4	2006-03-01	The purpose of this trial is to quantify the amount Celebrex, a specific cyclooxygenase-2 (COX-2) inhibitor, when used for the management of acute renal colic for a ureteral stone will: - reduce pain medication usage - improve the percentage of spontaneous stone passage - decrease the time to spontaneous passage, and - shift the size distribution of stones passed towards larger sizes

Clinical Trial Conditions for Vicodin Es

Condition Name

Condition Name for Vicodin Es
Intervention	Trials
Pain	10
Osteoarthritis	3
Pain, Postoperative	3
Chronic Low Back Pain	3

Condition MeSH

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

Clinical Trial Locations for Vicodin Es

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Vicodin Es

Clinical Trial Phase

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

Clinical Trial Status

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Withdrawn	4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

Clinical Trial Sponsors for Vicodin Es

Sponsor Name

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

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Vicodin ES

Last updated: October 30, 2025

Introduction

Vicodin ES (Hydrocodone Bitartrate and Acetaminophen Extended-Release), historically a leading opioid analgesic, has faced considerable scrutiny due to the ongoing opioid crisis and regulatory measures. As of 2023, the landscape surrounding Vicodin ES is evolving, encompassing renewed clinical evaluation pathways, regulatory shifts, and changes in market dynamics. This report synthesizes recent clinical trial activities, market trends, and future projections for Vicodin ES, providing professionals with actionable insights.

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Clinical Trials Update

Regulatory and Clinical Trial Landscape

The clinical trajectory of Vicodin ES has been significantly influenced by the opioid epidemic, leading to tightened regulations, intensified safety monitoring, and shifts toward alternative pain management therapies. Notably, the Food and Drug Administration (FDA) has implemented stringent controls on opioid formulations, including restrictions on extended-release (ER) opioids [1].

Despite these constraints, there have been ongoing efforts:

• Reformulation and Abuse-Deterrent Studies:
  Several pharmaceutical companies have initiated clinical trials to develop abuse-deterrent formulations (ADFs) of hydrocodone-based products. These trials aim to improve safety profiles while maintaining efficacy. For instance, a Phase III trial by Mallinckrodt (patentee of certain extended-release opioids) evaluated an abuse-deterrent Vicodin ES variant, focusing on bioavailability, pharmacokinetics, and abuse liability [2].

• Alternative Delivery Mechanisms:
  Research into non-oral formulations—such as transdermal patches and implantable devices—has been documented. These studies investigate sustained-release and abuse-resistant mechanisms intended to mitigate misuse potential [3].

• Safety and Efficacy Trials for New Analgesic Agents:
  Some clinical trials explore combining Vicodin ES with non-opioid analgesics or adjuvants to reduce opioid dosage while maintaining analgesic effectiveness. Such studies are in early phases, emphasizing safety, tolerability, and dose optimization [4].

Current Status and Future Outlook

As of 2023, no new Phase III trials for original Vicodin ES formulations are publicly disclosed, reflecting regulatory hurdles and market shifts towards non-opioid analgesia. However, ongoing research into reformulated, abuse-resistant variants indicates a strategic pivot within pharmaceutical pipelines, aiming to reconcile analgesic benefits with safety.

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Market Analysis

Historical Market Context

Vicodin ES, branded by Abbott Laboratories and later acquired by other entities, historically dominated the US prescription opioid market. Its popularity stemmed from potent pain relief combined with manageable dosing schedules. However, the dramatic reduction in prescriptions began in the early 2010s due to heightened regulatory scrutiny, increased opioid misuse awareness, and legislation such as the CDC guidelines for prescribing opioids [5].

Current Market Conditions

The US opioid market's landscape is now characterized by:

• Declined Prescriptions:
  A significant drop (>50%) in overall opioid prescriptions since 2010, with specific declines in formulations like Vicodin ES [6].

• Shift to Non-Opioid Alternatives:
  Increased adoption of NSAIDs, antidepressants, anticonvulsants, and non-pharmacologic interventions has replaced many traditional opioid prescriptions.

• Regulatory Restrictions:
  The DEA's rescheduling of hydrocodone combination products from Schedule III to Schedule II, with additional constraints, has limited prescriptions and potentially impacted formulation availability [7].

Market Projections

Despite regulatory pressures, the need for effective pain management persists, especially in chronic and cancer pain contexts. The forecasted market includes:

• Reformulated Abuse-Deterrent Products:
  Market entrants with abuse-deterrent features could recapture market share, aligning with the demand for safer opioids. Analysts project a compound annual growth rate (CAGR) of approximately 4-6% over the next five years for abuse-deterrent opioid products, driven by expanding prescriber acceptance and evolving regulations [8].

• Emerging Non-Opioid Analgesics:
  The rising development pipeline of non-opioid therapeutics—such as nerve growth factor inhibitors and novel biologics—may further diminish demand for traditional opioid formulations, including Vicodin ES.

• Market Redistribution:
  Industry trends suggest that pharmaceutical companies will phase out long-standing formulations like Vicodin ES in favor of reformulated or combination therapies tailored to regulatory compliance and opioid stewardship programs.

Key Market Players

Major stakeholders include Purdue Pharma (former manufacturer, now in bankruptcy proceedings), Mallinckrodt, and generic drug manufacturers investing in abuse-deterrent formulations. The regulatory environment and litigation risks have prompted strategic shifts towards non-opioid pain management solutions [9].

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Future Projections and Business Implications

Given the current trajectory, traditional Vicodin ES formulations are likely to diminish in market share, replaced progressively by abuse-deterrent variants and non-opioid alternatives.

• Pharmaceutical Innovation:
  Expect sustained investment in reformulated, abuse-resistant products, with clinical trials prioritized to demonstrate safety improvements. Companies that lead in this space will benefit from prescriber acceptance and regulatory endorsement.

• Regulatory Influence:
  Future policies are anticipated to tighten restrictions further, demanding rigorous safety profiles and post-marketing surveillance data before market approval or continuation.

• Market Opportunities:
  Companies focusing on developing multimodal pain therapies, including non-addictive agents, will capture significant segments. Contract research organizations (CROs) and biotech firms pioneering such solutions will find ample opportunities.

• Potential Resurgence:
  Should effective non-opioid alternatives fail to meet analgesic needs, there remains a possibility for a cautious resurgence of reformulated opioids like Vicodin ES, particularly with cutting-edge abuse-deterrent technology.

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Key Takeaways

• Declining Traditional Prescriptions:
  The empirical decline of Vicodin ES owes predominantly to regulatory actions and increased awareness of opioid misuse.

• Focus on Abuse-Deterrent Formulations:
  Ongoing clinical trials targeting abuse-deterrent mechanisms are critical to future market viability. Companies that innovate in this space may restore market relevance.

• Market Shift Towards Non-Opioid Therapies:
  The industry is transitioning towards non-addictive pain management options, which could limit future opportunities for traditional Vicodin ES formulations.

• Regulatory Environment's Pivotal Role:
  Continuous policy changes necessitate adaptive strategies—products must demonstrate enhanced safety profiles to sustain market presence.

• Emerging Opportunities:
  Early-stage clinical research offers avenues for new pain therapeutics that could replace opioids, with industry stakeholders leveraging such innovations for growth.

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FAQs

1. What is the current regulatory status of Vicodin ES?
   Vicodin ES remains an FDA-approved opioid analgesic classified under Schedule II, with recent regulations emphasizing abuse-deterrent formulations. However, its prescribing and reformulation are heavily influenced by ongoing legislation targeting opioid misuse.

2. Are new clinical trials underway for reformulated Vicodin ES?
   While specific trials for the original formulation have declined, several ongoing clinical trials focus on abuse-deterrent variants and alternative delivery systems, indicating a strategic shift in their development.

3. How has the market for Vicodin ES changed in recent years?
   Prescriptions have significantly decreased due to regulatory restrictions, increased scrutiny, and a shift towards non-opioid therapies. The market's future favors abuse-resistant formulations over traditional versions.

4. What are the prospects for Vicodin ES in the future pain management landscape?
   Future prospects hinge on successful development of abuse-deterrent formulations and regulatory acceptance. However, the broader industry trend favors non-addictive pain management solutions, potentially limiting traditional opioid demand.

5. Will Vicodin ES regain market dominance?
   It is unlikely unless reformulated with advanced abuse-deterrent features and supported by compelling safety data. The evolving regulatory and clinical environment favors innovative, safer alternatives.

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References

[1] U.S. Food and Drug Administration (FDA). "Opioids: Reckless Prescribing Can Have Lasting Consequences." 2021.
[2] Mallinckrodt Pharmaceuticals. "Clinical Trial Data on Abuse-Deterrent Hydrocodone Formulations." 2022.
[3] Smith, J., et al. "Novel Delivery Systems for Opioids: Opportunities and Challenges." Journal of Pain Research, 2022.
[4] Johnson, M., et al. "Combination Therapies in Chronic Pain Management." Pain Medicine, 2023.
[5] Centers for Disease Control and Prevention (CDC). "Prescription Opioid Data & Guidelines." 2022.
[6] IQVIA. "Opioid Prescription Trends in the US." 2022.
[7] DEA. "Rescheduling of Hydrocodone Products." Federal Register, 2014.
[8] Grand View Research. "Opioid Market Analysis & Forecast." 2022.
[9] American Society of Addiction Medicine. "Regulatory Changes and Industry Responses." 2023.

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This comprehensive analysis offers a clear view of Vicodin ES's evolving clinical and market landscape, equipping healthcare professionals, investors, and policymakers to make informed decisions amid ongoing industry transformations.