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 That study was repeated prospectively (unpublished) and confirmed that Dutch patients do not feel their pain is undertreated.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

Condition Name

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

Condition MeSH

Condition MeSH for Vicodin
Intervention	Trials
Pain, Postoperative	5
Osteoarthritis	4
Back Pain	3
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
Maryland	7
Florida	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

Vicodin: Clinical Trials, Market Analysis, and Projections

Last updated: December 31, 2024

Introduction to Vicodin

Vicodin, a combination of hydrocodone bitartrate and acetaminophen, is a widely used opioid medication for managing moderate to severe pain. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Recent Trials and Outcomes

In recent clinical trials, Vicodin has been compared to new non-opioid pain medications to assess efficacy and safety. For instance, Vertex Pharmaceuticals' phase 3 trials for their non-opioid pain medication, VX-548, included a comparison with Vicodin. While VX-548 met its primary endpoints by showing significant improvements in pain intensity compared to a placebo, it did not outperform Vicodin in all trials. In the bunionectomy trial, Vicodin (hydrocodone bitartrate and acetaminophen) performed significantly better than VX-548, highlighting the ongoing challenge of replacing opioids with non-opioid alternatives[1].

Safety and Abuse Concerns

Clinical trials and real-world data have consistently shown that hydrocodone, the opioid component of Vicodin, carries significant risks of misuse, abuse, and addiction. This has led to stricter regulations and the development of abuse-deterrent formulations. For example, the FDA has required extended-release and long-acting opioid analgesics, including hydrocodone products, to be part of a Risk Evaluation and Mitigation Strategy (REMS) to mitigate these risks[3][4].

Market Analysis

Current Market Landscape

The market for Vicodin and similar hydrocodone-based medications is influenced by several factors, including the growing prevalence of chronic pain conditions, an aging population, and heightened awareness of the opioid epidemic. Despite these challenges, the demand for effective pain relief medications remains high. The global hydrocodone market is expected to grow due to its widespread use in pain management, cough suppressants, and other medical applications[5].

Segment-wise Analysis

The hydrocodone market is segmented by application, with pain relief being the dominant segment. Hydrocodone is prescribed for moderate-to-severe pain, and its analgesic effects on the brain and spinal cord make it a preferred choice in many medical conditions. The North American market is anticipated to hold a significant share due to the high prevalence of arthritis and other pain-related conditions in the region[5].

Regional Insights

Europe is expected to account for a substantial revenue share in the hydrocodone market by 2037, driven by advancements in the healthcare sector and increased investment in medical research. The North American market, particularly the United States, will also remain significant due to the high incidence of arthritis and other diseases requiring pain management[5].

Market Projections

Growth Drivers

• Increasing Prevalence of Chronic Pain: The growing number of people suffering from chronic pain conditions such as cancer, arthritis, and post-surgical pain is driving the demand for hydrocodone-based medications.
• Advancements in Healthcare: Improvements in healthcare infrastructure and increased investment in medical research are expected to boost the market growth.
• Rising Aging Population: An aging population is more prone to chronic pain conditions, further increasing the demand for pain relief medications[5].

Challenges

• Opioid Epidemic: The ongoing opioid crisis has led to stricter regulations and increased scrutiny of prescription opioids, which may impact the market growth.
• Alternative Pain Management: The trend towards non-opioid and non-pharmacological pain management methods, such as physical therapy and acupuncture, is reducing the reliance on opioids like Vicodin[2].

Future Outlook

Regulatory Environment

The regulatory environment for hydrocodone products is becoming increasingly stringent. The FDA has implemented various measures, including REMS programs and the development of abuse-deterrent formulations, to mitigate the risks associated with opioid use. These regulations are expected to continue shaping the market for Vicodin and similar medications[3][4].

Research and Development

Pharmaceutical companies are focusing on developing safer and more effective pain management options. This includes the development of non-opioid pain medications and abuse-deterrent formulations of opioid medications. Initiatives like the FDA's Analgesic Clinical Trial Translation, Innovations, Opportunities, and Networks (ACTTION) Initiative aim to advance the development of novel pain medicines[4].

Key Takeaways

• Clinical Trials: Recent trials highlight the challenges in replacing opioids like Vicodin with non-opioid alternatives.
• Market Analysis: The hydrocodone market is driven by the need for effective pain relief, despite regulatory challenges.
• Projections: The market is expected to grow, particularly in regions with advancements in healthcare and a rising aging population.
• Regulatory Environment: Stricter regulations and the development of abuse-deterrent formulations will continue to shape the market.

FAQs

What are the primary challenges faced by Vicodin in clinical trials?

Vicodin faces challenges in clinical trials, particularly when compared to new non-opioid pain medications. These challenges include failing to be outperformed by opioids in some trials and the ongoing issue of abuse and addiction potential[1].

How is the regulatory environment impacting the hydrocodone market?

The regulatory environment is becoming increasingly stringent, with measures such as REMS programs and the development of abuse-deterrent formulations. These regulations aim to mitigate the risks associated with opioid use but may also impact market growth[3][4].

What are the growth drivers for the hydrocodone market?

The growth drivers include the increasing prevalence of chronic pain conditions, advancements in healthcare, and a rising aging population. These factors contribute to the ongoing demand for effective pain relief medications[5].

How is the trend towards non-opioid pain management affecting the market?

The trend towards non-opioid and non-pharmacological pain management methods is reducing the reliance on opioids like Vicodin. This shift is driven by patient awareness about the risks of opioids and the availability of alternative treatments[2].

What initiatives are being taken to develop safer pain management options?

Initiatives such as the FDA's ACTTION program and the development of abuse-deterrent formulations are aimed at advancing the development of safer and more effective pain management options[4].

Sources

1. Vertex's phase 3 pain trials hit goals but fail to beat Vicodin - Fierce Biotech
2. Acetaminophen/Hydrocodone (Vicodin) Manufacturing Plant Project Report 2024 - IMARC Group
3. Hydrocodone Bitartrate Extended-release Capsules (ZOHYDRO ER) - PBM VA
4. Overdose Prevention Activities Timeline - FDA
5. Hydrocodone Market Size & Share, Growth Report 2036 - Research Nester