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Last Updated: May 23, 2025

CLINICAL TRIALS PROFILE FOR HYDROCODONE BITARTRATE AND ACETAMINOPHEN


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All Clinical Trials for Hydrocodone Bitartrate And Acetaminophen

Trial ID Title Status Sponsor Phase Start Date Summary
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.
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 Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 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.
NCT01456520 ↗ Pharmacokinetics and Bioequivalence of Vycavert (10 mg Hydrocodone Bitartrate/325 mg Acetaminophen) Compared to the Reference Drug Norco Completed Pfizer Phase 1 2011-10-01 This study aims to determine whether the hydrocodone and acetaminophen exposures following oral dosing of Vycavert are comparable to those following oral dosing of Norco.
NCT01596673 ↗ A Study to Assess the Abuse Potential of Hydrocodone Extended-Release Tablet in Recreational Opioid Users Completed Cephalon Phase 1 2012-03-01 The purpose of this study is to assess the relative abuse potential of the hydrocodone bitartrate extended-release tablet compared to immediate-release hydrocodone bitartrate.
NCT01759446 ↗ Abuse Potential of Intranasal VYCAVERT Tablets (Hydrocodone Bitartrate/Acetaminophen) in Recreational Opioid Users Completed Acura Pharmaceuticals Inc. Phase 2 2013-02-01 To determine the relative abuse potential of VYCAVERT (hydrocodone bitartrate and acetaminophen) compared to GENERIC H/A (hydrocodone bitartrate and acetaminophen) when crushed and administered intranasally to non dependent, recreational opioid users.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Hydrocodone Bitartrate And Acetaminophen

Condition Name

Condition Name for Hydrocodone Bitartrate And Acetaminophen
Intervention Trials
Opioid-Related Disorders 3
Pain, Acute 2
Pain, Postoperative 2
Healthy 2
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Condition MeSH

Condition MeSH for Hydrocodone Bitartrate And Acetaminophen
Intervention Trials
Opioid-Related Disorders 3
Pain, Postoperative 2
Acute Pain 2
Substance-Related Disorders 1
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Clinical Trial Locations for Hydrocodone Bitartrate And Acetaminophen

Trials by Country

Trials by Country for Hydrocodone Bitartrate And Acetaminophen
Location Trials
United States 10
Canada 2
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Trials by US State

Trials by US State for Hydrocodone Bitartrate And Acetaminophen
Location Trials
Utah 3
Kansas 2
Texas 1
Maryland 1
California 1
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Clinical Trial Progress for Hydrocodone Bitartrate And Acetaminophen

Clinical Trial Phase

Clinical Trial Phase for Hydrocodone Bitartrate And Acetaminophen
Clinical Trial Phase Trials
Phase 3 2
Phase 2 1
Phase 1 5
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Clinical Trial Status

Clinical Trial Status for Hydrocodone Bitartrate And Acetaminophen
Clinical Trial Phase Trials
Completed 6
Withdrawn 2
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Clinical Trial Sponsors for Hydrocodone Bitartrate And Acetaminophen

Sponsor Name

Sponsor Name for Hydrocodone Bitartrate And Acetaminophen
Sponsor Trials
Grünenthal GmbH 2
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 1
Pfizer 1
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Sponsor Type

Sponsor Type for Hydrocodone Bitartrate And Acetaminophen
Sponsor Trials
Industry 10
Other 2
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Hydrocodone Bitartrate and Acetaminophen: Clinical Trials, Market Analysis, and Projections

Introduction

Hydrocodone bitartrate and acetaminophen is a widely used combination medication for managing moderate to severe pain. This article delves into the clinical trials, market analysis, and future projections for this drug.

Clinical Efficacy and Trials

Comparative Studies

A prospective, randomized, blinded clinical study compared the pharmacodynamics of hydrocodone bitartrate–acetaminophen and tramadol hydrochloride in dogs undergoing tibial plateau leveling osteotomy (TPLO). The study found that hydrocodone-acetaminophen provided better postoperative analgesia compared to tramadol when administered at 8-hour intervals[1].

In human studies, hydrocodone bitartrate extended-release (Hysingla ER) was evaluated in a 12-week, randomized, double-blind, placebo-controlled study for patients with uncontrolled moderate to severe chronic low back pain. The results showed that Hysingla ER provided effective analgesia, with higher responder rates compared to the placebo group[2].

Safety and Adverse Events

The safety profile of hydrocodone bitartrate and acetaminophen is well-documented. Common adverse events include nausea, vomiting, constipation, and dizziness, which are typical for opioid analgesics. Long-term safety data from a 12-month open-label study indicated that while the drug is generally safe, it can lead to significant adverse events, including multi-drug overdose in some cases[2].

Abuse-Deterrent Formulations

Studies have also focused on the development of abuse-deterrent formulations. For example, MNK-155, an extended-release oral formulation of hydrocodone and acetaminophen, demonstrated lower measures of drug liking, drug high, and good drug effects compared to immediate-release formulations. This suggests a reduced potential for abuse[5].

Market Analysis

Current Market Position

Hydrocodone bitartrate and acetaminophen combination products, such as Vicodin, are among the most commonly prescribed opioid analgesics. The market demand is driven by the need for effective pain management, particularly for patients with moderate to severe pain who do not respond well to other pain medications[4].

Competitors and Alternatives

The market for opioid analgesics is competitive, with alternatives such as morphine sulfate sustained-action tablets, fentanyl transdermal patches, and oxycodone HCL ER tablets. However, hydrocodone bitartrate and acetaminophen remain a preferred choice due to their established efficacy and relatively lower cost compared to some other opioids[2].

Regulatory Environment

Hydrocodone bitartrate is a Schedule II controlled substance, which imposes strict regulations on its prescription and distribution. This regulatory environment can impact market dynamics but also ensures that the drug is used responsibly and under medical supervision[2].

Market Projections

Growing Demand for Pain Management

The demand for effective pain management solutions is expected to grow, driven by an aging population and an increase in chronic pain conditions. Hydrocodone bitartrate and acetaminophen are likely to remain a key part of this market due to their proven efficacy and widespread use[4].

Innovations in Formulations

The development of abuse-deterrent formulations, such as MNK-155, is expected to further solidify the market position of hydrocodone bitartrate and acetaminophen. These formulations address concerns about opioid abuse while maintaining therapeutic efficacy[5].

Economic Factors

The cost-effectiveness of hydrocodone bitartrate and acetaminophen compared to other opioid analgesics will continue to influence market projections. As healthcare systems seek to manage costs, this combination medication is likely to remain a preferred option[2].

Safety Considerations and Public Health Impact

Opioid Abuse and Misuse

The opioid crisis has highlighted the need for careful prescribing practices and monitoring of opioid use. Hydrocodone bitartrate and acetaminophen, like other opioids, carry a risk of abuse and misuse. Public health initiatives and regulatory measures aim to mitigate these risks while ensuring access to necessary pain management[2].

Liver Damage from Acetaminophen

Acetaminophen, a component of the combination, can cause liver damage at high doses. Public health campaigns and medical guidelines emphasize the importance of adhering to recommended dosages to avoid such adverse effects[4].

Key Takeaways

  • Clinical Efficacy: Hydrocodone bitartrate and acetaminophen have been shown to be effective in managing moderate to severe pain in both human and veterinary studies.
  • Safety Profile: Common adverse events include nausea, vomiting, and dizziness, with a risk of abuse and misuse.
  • Market Position: The combination remains a widely prescribed opioid analgesic due to its efficacy and cost-effectiveness.
  • Innovations: Abuse-deterrent formulations are being developed to reduce the potential for abuse.
  • Regulatory Environment: Strict regulations govern the use of hydrocodone bitartrate due to its Schedule II classification.

FAQs

What is the primary use of hydrocodone bitartrate and acetaminophen?

Hydrocodone bitartrate and acetaminophen are used to relieve pain severe enough to require opioid treatment and when other pain medicines have not worked well or cannot be tolerated[4].

What are the common adverse events associated with hydrocodone bitartrate and acetaminophen?

Common adverse events include nausea, vomiting, constipation, and dizziness, which are typical for opioid analgesics[2].

How does the abuse-deterrent formulation of hydrocodone bitartrate and acetaminophen work?

Abuse-deterrent formulations, such as MNK-155, demonstrate lower measures of drug liking, drug high, and good drug effects, and take longer to reach peak drug effect, reducing the potential for abuse[5].

Can hydrocodone bitartrate and acetaminophen be used in elderly patients?

While there are no geriatric-specific problems that limit the usefulness of hydrocodone and acetaminophen in the elderly, caution and dose adjustments may be necessary due to age-related health issues[4].

What are the risks associated with long-term use of hydrocodone bitartrate and acetaminophen?

Long-term use can lead to significant adverse events, including the risk of multi-drug overdose. Additionally, acetaminophen can cause liver damage at high doses[2][4].

Sources

  1. Clinical efficacy of hydrocodone-acetaminophen and tramadol for postoperative pain in dogs undergoing tibial plateau leveling osteotomy. American Journal of Veterinary Research, 76(9), 755-763.
  2. Hydrocodone Bitartrate Extended-Release Tablets (Hysingla ER), C-II. VA National Formulary, 2023.
  3. Relative Bioavailability, Intranasal Abuse Potential, and Safety of Benzhydrocodone/APAP Compared With Hydrocodone Bitartrate/APAP. Pain Medicine, 19(5), 955-966.
  4. Hydrocodone and acetaminophen (oral route). Mayo Clinic, 2024.
  5. MNK-155 is an investigational extended-release oral formulation of hydrocodone and acetaminophen. Mallinckrodt Pharmaceuticals, 2014.
Last updated: 2024-12-31

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