CLINICAL TRIALS PROFILE FOR VICODIN HP

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

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 That study was repeated prospectively (unpublished) and confirmed that Dutch patients do not feel their pain is undertreated.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

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
NCT00304317 ↗	Celecoxib (Celebrex) in the Management of Acute Renal Colic	Withdrawn	University of Minnesota	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 Hp

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for Vicodin Hp

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Vicodin Hp

Clinical Trial Phase

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

Clinical Trial Status

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Withdrawn	4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

Clinical Trial Sponsors for Vicodin Hp

Sponsor Name

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

Sponsor Type

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

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

Last updated: October 28, 2025

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Introduction

Vicodin HP, a combination analgesic comprising hydrocodone and acetaminophen, remains a critical product within the pain management segment. Despite evolving regulatory landscapes and market threats from generics and alternative therapies, Vicodin HP continues to influence patient care and pharmaceutical strategies. This report provides a comprehensive update on clinical trials, analyzes current market dynamics, and forecasts future performance for Vicodin HP.

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Clinical Trials Update

Regulatory Environment and Clinical Development

Vicodin HP, marketed primarily by AbbVie (formerly part of Abbott Laboratories), has historically been used for moderate-to-severe pain management. As of 2023, efforts to modify formulations—such as reducing opioid content or developing abuse-deterrent versions—indicate ongoing clinical interest.

Recent clinical trial activity predominantly pertains to abuse-deterrent formulations (ADFs). These trials aim to mitigate misuse and addiction potential linked to hydrocodone-based medications. The U.S. Food and Drug Administration (FDA) has prioritized such formulations, with several investigational studies assessing physical and chemical barriers to tampering.

Current and Notable Trials

• Phase IV Post-Marketing Studies: Ongoing real-world assessments aim to evaluate the safety profile of Vicodin HP in combination with monitoring adherence and misuse patterns, especially amid the opioid crisis.

• Formulation Enhancement Trials: Several trials, including those registered on ClinicalTrials.gov (e.g., NCT04567732), evaluate novel abuse-deterrent formulations designed to retain analgesic efficacy while reducing misuse potential.

• Generic Developmental Trials: The expiry of patent protections and the rising prevalence of generics have spurred a rising number of bioequivalence studies and manufacturing approval applications aiming to bring alternative formulations to market, intensifying competition.

Regulatory Posture and Implications

The FDA continues to enforce stricter prescribing guidelines for opioid products, including Vicodin HP. Trial data demonstrating improved safety profiles or abuse deterrence significantly influence marketing approvals and clinical acceptance. Pending initiatives include integrating digital health tools, such as electronic pill dispensers, which could be evaluated in upcoming trials.

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Market Analysis

Current Market Landscape

The Vicodin HP market is chiefly impacted by factors such as regulatory scrutiny, the opioid epidemic, and the advent of non-opioid analgesics. In 2022, the United States accounted for the largest share of the global opioid analgesics market, projected to grow at a CAGR of 3.4% from 2022-2027 [1].

Market Share and Competition

Despite patent expirations and the proliferation of alternative pain medications, Vicodin HP retains a significant market share due to brand loyalty, physician prescribing habits, and formulary placements. However, competition has intensified with:

• Generics: A surge in FDA-approved hydrocodone-acetaminophen generics has diluted brand market share.
• Alternative Analgesics: Non-opioid options, including NSAIDs, acetaminophen, and nerve pain agents, are increasingly preferred for safety concerns.
• Abuse-Deterrent Formulations: New ADF products, like Xtampza ER and reformulated opioids, pose a threat to traditional formulations.

Regulatory and Societal Influences

Stringent federal and state regulations, prescribing guidelines (e.g., CDC guidelines), and public health campaigns have curtailed overall opioid utilization. Retail pharmacies and hospitals have aligned procurement policies favoring safer alternatives, contributing to declining prescription volumes for Vicodin HP.

Market Projection

Given current trends, the global opioid analgesics market is expected to expand modestly, reaching approximately USD 13.5 billion by 2027 [1]. However, Vicodin HP’s share is projected to decline at an estimated CAGR of 2-3%, influenced by:

• Increased adoption of abuse-deterrent and reformulated products.
• Policy-driven reductions in opioid prescriptions.
• Growing preference for multimodal pain management strategies.

Nonetheless, Vicodin HP may maintain niche markets due to certain patient populations with limited options, especially where tolerability and cost remain considerations.

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Future Outlook and Strategic Implications

Potential Growth Avenues

• Reformulation and Abuse-Deterrence: Continued development and approval of abuse-resistant formulations can help sustain market relevance.
• Targeting Specific Markets: Focus on under-served demographics such as rural or opioid-tolerant patients may preserve niche demand.
• Combination with Digital Health Tools: Incorporating adherence monitoring could differentiate future products and improve safety profiles.

Challenges

• Pricing and Reimbursement: Contract negotiations and payer restrictions may limit market access.
• Regulatory Barriers: Increasing oversight and potential reclassification impact prescription volumes.
• Legal Risks: Litigations associated with opioid use and marketing remain significant concerns.

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Key Takeaways

• Clinical trial activity centers on developing abuse-deterrent formulations to align with regulatory priorities and mitigate misuse.
• Market dynamics indicate a declining trend for Vicodin HP, driven by regulatory restrictions, safety concerns, and competition from generics and non-opioid alternatives.
• Future growth hinges on reformulation efforts and strategic positioning within regulatory frameworks emphasizing safety.
• The opioid market is increasingly consolidated, with growth primarily in specialized formulations and niche applications.
• Risk mitigation strategies, including digital health integration and targeted marketing, are vital for maintaining relevance in a shrinking traditional opioid market.

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FAQs

1. What are the primary regulatory challenges facing Vicodin HP?
Regulatory agencies like the FDA have implemented strict guidelines to curb opioid misuse, including increased oversight, abuse-deterrent requirements, and prescribing restrictions, which can limit market access and usability of Vicodin HP.

2. How does the rise of abuse-deterrent formulations affect Vicodin HP's market?
Abuse-deterrent formulations aim to reduce misuse, potentially extending Vicodin HP's market lifespan if reformulated versions gain approval. However, the transition may cause temporary decline as prescribers and patients shift.

3. Are there new clinical trials threatening Vicodin HP’s dominance?
Yes, ongoing trials exploring reformulated opioid products with improved safety profiles may replace traditional Vicodin HP in certain clinical settings.

4. What's the outlook for Vicodin HP amidst the opioid epidemic?
While the overall market is shrinking, Vicodin HP remains relevant in specific patient groups. Its future depends on reformulation success and regulatory adaptation.

5. How do generics influence the competitive landscape?
The availability of cheaper generic hydrocodone-acetaminophen products significantly reduces brand-driven market share, compelling brand manufacturers to innovate and differentiate.

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References

1. MarketWatch. (2022). Opioid analgesics market size and forecast.
2. ClinicalTrials.gov. Registry of ongoing Vicodin-related trials.
3. FDA. Guidance on abuse-deterrent opioids, 2019.
4. Grand View Research. (2022). Global pain management pharmaceuticals market analysis.