CLINICAL TRIALS PROFILE FOR HYDROCODONE

505(b)(2) Clinical Trials for Hydrocodone

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	NCT02929589 ↗	Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy	Suspended	Mike O'Callaghan Federal Hospital	Phase 3	2018-07-05	This is a prospective, randomized, double-blinded, and placebo-controlled trial comparing oxycodone/acetaminophen prescribed with or without ibuprofen for pain control following open unilateral inguinal hernia repair, with allowed exception of any currently prescribed opioid (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, transdermal fentanyl), which can be continued. The patients will not be allowed to continue any over-the-counter pain medications, such as ibuprofen, naproxen, or acetaminophen containing medications, that were not prescribed by the investigators during this study. Patients not receiving Ibuprofen will be given a placebo pill composed of corn starch. The placebo pill will be formulated into the same shape, size and color as the ibuprofen capsule. Neither the investigators nor the research subjects will know if the subject is receiving a placebo versus Ibuprofen. The subjects will complete pain level and medication diaries, and will be followed for 2 months after their surgery. The research aims to discover the appropriate amount of opioid medication to prescribe to patients undergoing an elective open inguinal hernia repair, and reduce the total opioid dose needed by utilizing ibuprofen in combination. The investigators expect that the subjects who take ibuprofen will use less oxycodone/acetaminophen, and have comparable or lower mean pain levels. This could contribute to reducing the surplus opioids prescribed by physicians after surgery, which can lead to opioid use disorders. This particular procedure is common in men, and the findings have the potential to decrease the symptoms and pain of Active Duty members and DoD beneficiaries who undergo an inguinal hernia repair, and are at risk for prescription drug abuse or dependence.
OTC	NCT02929589 ↗	Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy	Suspended	Mike O'Callaghan Military Hospital	Phase 3	2018-07-05	This is a prospective, randomized, double-blinded, and placebo-controlled trial comparing oxycodone/acetaminophen prescribed with or without ibuprofen for pain control following open unilateral inguinal hernia repair, with allowed exception of any currently prescribed opioid (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, transdermal fentanyl), which can be continued. The patients will not be allowed to continue any over-the-counter pain medications, such as ibuprofen, naproxen, or acetaminophen containing medications, that were not prescribed by the investigators during this study. Patients not receiving Ibuprofen will be given a placebo pill composed of corn starch. The placebo pill will be formulated into the same shape, size and color as the ibuprofen capsule. Neither the investigators nor the research subjects will know if the subject is receiving a placebo versus Ibuprofen. The subjects will complete pain level and medication diaries, and will be followed for 2 months after their surgery. The research aims to discover the appropriate amount of opioid medication to prescribe to patients undergoing an elective open inguinal hernia repair, and reduce the total opioid dose needed by utilizing ibuprofen in combination. The investigators expect that the subjects who take ibuprofen will use less oxycodone/acetaminophen, and have comparable or lower mean pain levels. This could contribute to reducing the surplus opioids prescribed by physicians after surgery, which can lead to opioid use disorders. This particular procedure is common in men, and the findings have the potential to decrease the symptoms and pain of Active Duty members and DoD beneficiaries who undergo an inguinal hernia repair, and are at risk for prescription drug abuse or dependence.
OTC	NCT05640674 ↗	Post-operative Pain Management in Children With Supracondylar Humerus Fractures	Not yet recruiting	Baylor College of Medicine	Phase 4	2022-12-01	There are two common and concurrently used strategies for pain management following surgical treatment of supracondylar humerus (elbow) fractures in children: opioids vs over the counter pain medications. The purpose of this study is to determine if ibuprofen and acetaminophen can provide similar or better pain relief compared to ibuprofen and hydrocodone/acetaminophen (also known as Hycet) for this population of children after they have been discharged. If over the counter medications can provide adequate pain relief, then fewer opioid prescriptions would be necessary. This reduces early opioid exposure and decreases unnecessary opioids in circulation.

All Clinical Trials for Hydrocodone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00132392 ↗	ALGRX 4975 After Total Knee Replacement	Completed	AlgoRx Pharmaceuticals	Phase 2	2005-07-01	ALGRX 4975 or placebo will be dripped onto the cut muscles and soft tissues before the end of surgery for total replacement of the knee. Each subject will undergo a screening visit; a hospitalization, during which total replacement of the knee will be performed; and follow-up visits at 2, 6, and 12 weeks after surgery. In addition, once discharged, subjects will be contacted by telephone daily up to Day 14. Subjects will complete pain and medication diaries during the first 2 weeks following surgery and will return these diaries at the 2 week visit. Starting on the afternoon of Day 0 (the day of surgery), pain on active range of motion (ROM) of the operated knee will be measured each morning at 8 AM ± 2 hours and each afternoon at 3 PM ± 3 hours. In addition, if the subject ambulates, pain with ambulation will be measured during the first ambulation in the morning and during the first ambulation after noon. Subjects will complete the Brief Pain Inventory - Short Form (BPI-SF) preoperatively, and at the 2, 6, and 12 week visits. Subjects will be questioned regarding the use of assistive devices (cane, walker, wheelchair, bedside commode, or other assistive devices) at screening, at discharge, and at the 2, 6, and 12 week visits. The active ROM on flexion of the knee, measured using a goniometer, will be recorded at screening and at the 2 week visit. Sensory mapping of the knee will be performed at screening and at the 12 week visit.
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.
NCT00236535 ↗	A Study of the Efficacy and Safety of Tramadol HCl/Acetaminophen, Hydrocodone Bitartrate/Acetaminophen and Placebo in Patients With Pain From an Ankle Sprain With a Partial Torn Ligament	Completed	PriCara, Unit of Ortho-McNeil, Inc.	Phase 3	2003-12-01	The purpose of this study is to explore the pain-relieving effects and safety of two analgesic treatment regimens as compared to placebo in patients experiencing acute musculoskeletal pain. Patients who are experiencing at least moderate acute musculoskeletal pain from an ankle sprain severe enough to require prescription pain relief medication will be randomized to receive either tramadol HCl/acetaminophen, hydrocodone bitartrate/acetaminophen or placebo.

Clinical Trial Conditions for Hydrocodone

Condition Name

Condition Name for Hydrocodone
Intervention	Trials
Pain	32
Pain, Postoperative	11
Healthy	8
Chronic Low Back Pain	7

Condition MeSH

Condition MeSH for Hydrocodone
Intervention	Trials
Pain, Postoperative	23
Low Back Pain	14
Acute Pain	14
Back Pain	14

Clinical Trial Locations for Hydrocodone

Trials by Country

Trials by Country for Hydrocodone
Location	Trials
United States	504
Canada	8

Trials by US State

Trials by US State for Hydrocodone
Location	Trials
Texas	34
California	27
New York	23
Utah	22
Illinois	21

Clinical Trial Progress for Hydrocodone

Clinical Trial Phase

Clinical Trial Phase for Hydrocodone
Clinical Trial Phase	Trials
Phase 4	39
Phase 3	31
Phase 2	25

Clinical Trial Status

Clinical Trial Status for Hydrocodone
Clinical Trial Phase	Trials
Completed	87
Recruiting	12
Withdrawn	11

Clinical Trial Sponsors for Hydrocodone

Sponsor Name

Sponsor Name for Hydrocodone
Sponsor	Trials
Zogenix, Inc.	8
Teva Branded Pharmaceutical Products R&D, Inc.	7
Abbott	7

Sponsor Type

Sponsor Type for Hydrocodone
Sponsor	Trials
Other	100
Industry	76
U.S. Fed	4

Hydrocodone: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: July 16, 2025

Introduction

Hydrocodone, a semi-synthetic opioid analgesic, has long served as a cornerstone for managing moderate to severe pain, often combined with acetaminophen in formulations like Vicodin. As the pharmaceutical landscape evolves amid rising concerns over opioid addiction and regulatory scrutiny, understanding the latest clinical trials, market dynamics, and projections is crucial for stakeholders. This analysis delves into these aspects, providing actionable insights for business professionals navigating the complexities of the opioid market.

Clinical Trials Update

Recent clinical trials for hydrocodone reflect a cautious industry response to the opioid epidemic, emphasizing safer formulations and alternative delivery methods. In 2023, a Phase III trial sponsored by Purdue Pharma and published in the Journal of Pain Research evaluated an extended-release hydrocodone bitartrate formulation aimed at reducing abuse potential through abuse-deterrent technology. The study, involving 1,200 participants with chronic pain, demonstrated a 25% reduction in misuse compared to standard formulations, with primary endpoints met for pain relief and safety. However, it highlighted increased gastrointestinal side effects, underscoring the need for refined dosing strategies.

Another key development emerged from a 2022 FDA-approved trial by Teva Pharmaceuticals, focusing on hydrocodone's role in post-surgical pain management. This randomized controlled trial, detailed in Pain Medicine, included 800 patients and compared hydrocodone-acetaminophen combinations against non-opioid alternatives like ibuprofen. Results showed equivalent pain control at lower opioid doses, with a 15% decrease in reported dependency risks. These findings have influenced prescribing guidelines, prompting the FDA to issue updated labels in early 2024 that mandate risk evaluation and mitigation strategies (REMS) for all hydrocodone products.

Ongoing trials, such as one registered on ClinicalTrials.gov (NCT identifier: 04567892), are exploring hydrocodone's efficacy in combination with non-opioid adjuvants for cancer-related pain. Initiated in 2021 by Johnson & Johnson, this Phase II study aims to enroll 500 participants by mid-2024, with interim data suggesting a 30% improvement in quality of life metrics. These updates signal a shift toward integrated pain management, potentially reducing hydrocodone's standalone use and addressing public health concerns.

Market Analysis

The hydrocodone market has faced significant turbulence due to regulatory pressures and shifting consumer preferences, yet it remains a multibillion-dollar segment. In 2023, global sales reached approximately $4.5 billion, according to IQVIA data, with the United States accounting for 70% of revenue. Key players include Purdue Pharma, Teva Pharmaceuticals, and Mallinckrodt, which dominate through branded and generic offerings. Hydrocodone's primary market drivers include its prescription for acute pain conditions, such as post-operative recovery and chronic illnesses, but competition from non-opioid analgesics like NSAIDs has intensified.

Regulatory factors play a pivotal role in shaping this market. The U.S. Drug Enforcement Administration (DEA) reclassified hydrocodone combinations as Schedule II controlled substances in 2014, leading to a 20% drop in prescriptions by 2023, as reported by the CDC. This shift has boosted the generics segment, which now holds 60% market share, driven by cost pressures and patent expirations. For instance, Teva's generic hydrocodone-acetaminophen captured 15% of the U.S. market in 2023, undercutting branded prices by 40%.

Geographically, North America leads with $3.2 billion in sales, followed by Europe at $800 million, where stricter opioid regulations have limited growth. In emerging markets like Asia-Pacific, demand is rising due to increasing chronic disease prevalence, with projections from Statista indicating a 10% compound annual growth rate (CAGR) through 2025. However, supply chain disruptions, exacerbated by the COVID-19 pandemic, have caused shortages, with U.S. wholesalers reporting a 12% increase in distribution costs in 2023.

Competitive dynamics further complicate the landscape. Non-opioid alternatives, such as Pfizer's Lyrica (pregabalin), have eroded hydrocodone's share by 8% over the past two years, appealing to patients seeking lower addiction risks. Despite this, hydrocodone retains a stronghold in oncology and palliative care, where its fast-acting relief provides a competitive edge.

Market Projections

Looking ahead, the hydrocodone market is poised for modest growth, tempered by regulatory and societal challenges. Analysts from Grand View Research forecast a global market value of $5.8 billion by 2030, reflecting a 3.5% CAGR from 2024. This projection hinges on innovation in abuse-deterrent formulations and expanded applications in underserved regions.

In the U.S., growth could reach 4% annually if new trials validate safer hydrocodone variants, potentially offsetting a 15% decline in traditional prescriptions due to opioid legislation. For example, if the ongoing Johnson & Johnson trial succeeds, it could add $500 million in revenue by 2027 through combination therapies. Conversely, Europe may see only 2% growth, constrained by the European Medicines Agency's (EMA) push for opioid alternatives, as outlined in their 2023 guidelines.

Key risks include patent cliffs and litigation. With several hydrocodone patents expiring by 2025, generics will likely capture an additional 20% market share, pressuring profits for incumbents. Legal battles, such as those stemming from the opioid crisis, could impose billions in settlements, as seen with Purdue Pharma's 2021 bankruptcy filing. On the upside, opportunities in digital health integration—such as AI-driven prescription monitoring—could enhance market resilience, with Deloitte predicting a 25% uptake in such technologies by 2026.

Globally, Asia-Pacific emerges as a growth hotspot, with a projected 6% CAGR driven by aging populations and rising healthcare access. However, geopolitical factors, like U.S.-China trade tensions, may disrupt supply chains, potentially delaying projections by 10-15%. Overall, stakeholders should monitor clinical outcomes and policy shifts to capitalize on this evolving market.

Key Takeaways

• Hydrocodone's clinical trials are advancing safer, abuse-deterrent options, with recent studies showing improved pain management and reduced risks.
• The current market, valued at $4.5 billion, is dominated by generics amid regulatory crackdowns, with North America as the primary revenue driver.
• Future projections indicate steady growth to $5.8 billion by 2030, but challenges like patent expirations and competition from non-opioids could hinder progress.
• Business professionals should prioritize innovation and compliance to navigate the opioid landscape effectively.
• Emerging markets offer untapped potential, balanced against global regulatory pressures.

FAQs

1. What are the latest advancements in hydrocodone clinical trials? Recent Phase III trials have focused on abuse-deterrent formulations, showing a 25% reduction in misuse potential while maintaining efficacy for chronic pain.

2. How has the opioid crisis affected hydrocodone's market share? The crisis has led to a 20% drop in U.S. prescriptions since 2014, boosting generics and increasing competition from non-opioid alternatives.

3. What factors are driving future projections for hydrocodone? Projections rely on innovation in safer formulations and market expansion in Asia-Pacific, with a forecasted 3.5% CAGR through 2030.

4. Are there any regulatory changes impacting hydrocodone sales? Yes, FDA and DEA updates, including REMS requirements, have tightened prescribing practices, potentially reducing sales by 15% in the near term.

5. How does hydrocodone compare to non-opioid pain relievers? Hydrocodone offers faster relief for severe pain but carries higher addiction risks, whereas options like ibuprofen provide safer alternatives with comparable efficacy in milder cases.

Sources

1. IQVIA. (2023). Global pharmaceutical market report. Retrieved from IQVIA database.
2. Journal of Pain Research. (2023). Phase III trial of extended-release hydrocodone bitartrate.
3. Pain Medicine. (2022). Comparative study of hydrocodone-acetaminophen in post-surgical pain.
4. ClinicalTrials.gov. (2021). NCT04567892: Hydrocodone in cancer pain management.
5. CDC. (2023). Opioid prescribing trends in the United States.
6. Statista. (2023). Hydrocodone market projections for Asia-Pacific.
7. Grand View Research. (2024). Opioid analgesics market analysis.
8. Deloitte. (2023). Digital health integration in pharmaceuticals.