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Last Updated: January 6, 2025

CLINICAL TRIALS PROFILE FOR DILAUDID


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505(b)(2) Clinical Trials for DILAUDID

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial TypeTrial IDTitleStatusSponsorPhaseStart DateSummary
OTC NCT00245375 ↗ A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery Completed McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. N/A 2005-01-01 Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.
OTC NCT00245375 ↗ A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery Completed Nova Scotia Health Authority N/A 2005-01-01 Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 2 of 2 entries

All Clinical Trials for DILAUDID

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00175357 ↗ NAOMI: A Study to Compare Medically-prescribed Heroin With Oral Methadone in Chronic Opiate Addiction Completed Canadian Institutes of Health Research (CIHR) Phase 3 2005-03-01 The objective of this study is to determine whether the closely supervised provision of injectable, pharmaceutical-grade heroin (in combination with oral methadone) is more effective than methadone therapy alone in recruiting, retaining, and benefiting long-term heroin users who have not been helped by current standard treatment options.
NCT00175357 ↗ NAOMI: A Study to Compare Medically-prescribed Heroin With Oral Methadone in Chronic Opiate Addiction Completed University of British Columbia Phase 3 2005-03-01 The objective of this study is to determine whether the closely supervised provision of injectable, pharmaceutical-grade heroin (in combination with oral methadone) is more effective than methadone therapy alone in recruiting, retaining, and benefiting long-term heroin users who have not been helped by current standard treatment options.
NCT00195910 ↗ Safety and Efficacy Study of Hydromorphone and Morphine Completed Chang, Andrew, M.D. Phase 2 2004-10-01 To compare a standard weight-based dose of intravenous (IV) hydromorphone (Dilaudid) to a standard weight-based dose of IV morphine in adults presenting to the Emergency Department (ED) with acute severe pain.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for DILAUDID

Condition Name

281290051015202530PainAcute PainPain, Postoperative[disabled in preview]
Condition Name for DILAUDID
Intervention Trials
Pain 28
Acute Pain 12
Pain, Postoperative 9
[disabled in preview] 0
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Condition MeSH

211470-20246810121416182022Acute PainPain, PostoperativeOpioid-Related Disorders[disabled in preview]
Condition MeSH for DILAUDID
Intervention Trials
Acute Pain 21
Pain, Postoperative 14
Opioid-Related Disorders 7
[disabled in preview] 0
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Clinical Trial Locations for DILAUDID

Trials by Country

+
Trials by Country for DILAUDID
Location Trials
United States 98
Canada 13
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Trials by US State

+
Trials by US State for DILAUDID
Location Trials
New York 25
Ohio 9
California 7
Texas 7
Maryland 6
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Clinical Trial Progress for DILAUDID

Clinical Trial Phase

53.6%42.9%0051015202530Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for DILAUDID
Clinical Trial Phase Trials
Phase 4 30
Phase 3 24
Phase 2/Phase 3 2
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Clinical Trial Status

74.1%15.3%10.6%00102030405060CompletedTerminatedRecruiting[disabled in preview]
Clinical Trial Status for DILAUDID
Clinical Trial Phase Trials
Completed 63
Terminated 13
Recruiting 9
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Clinical Trial Sponsors for DILAUDID

Sponsor Name

trials02468101214Montefiore Medical CenterAlza Corporation, DE, USAM.D. Anderson Cancer Center[disabled in preview]
Sponsor Name for DILAUDID
Sponsor Trials
Montefiore Medical Center 13
Alza Corporation, DE, USA 11
M.D. Anderson Cancer Center 4
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Sponsor Type

75.7%16.4%7.9%0020406080100120OtherIndustryNIH[disabled in preview]
Sponsor Type for DILAUDID
Sponsor Trials
Other 115
Industry 25
NIH 12
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DILAUDID Market Analysis and Financial Projection

Dilaudid (Hydromorphone): Clinical Trials, Market Analysis, and Projections

Introduction

Dilaudid, known generically as hydromorphone, is a potent opioid analgesic used for the relief of moderate to severe pain. This article will delve into recent clinical trials, market analysis, and projections for this drug, highlighting its efficacy, market trends, and future outlook.

Clinical Trials: Efficacy and Safety

Comparison with Diacetylmorphine

A significant clinical trial, the SALOME study, compared the efficacy of injectable hydromorphone with injectable diacetylmorphine (the active ingredient in heroin) for individuals with long-term opioid dependence. This phase 3, double-blind, noninferiority trial randomized participants to receive either injectable diacetylmorphine or hydromorphone for six months. The results indicated that hydromorphone is as effective as diacetylmorphine in reducing street heroin use and total use of any street-acquired opioids, with high treatment retention rates (>80%) similar to those seen in previous diacetylmorphine studies[1].

Pain Management

In the context of pain management, hydromorphone has been extensively studied. For example, a multicenter study involving patients with cancer or non-cancer pain showed that switching from other opioids to the OROS (Osmotic [Controlled] Release Oral delivery System) hydromorphone extended-release preparation provided good pain control and was well tolerated. It typically took about twelve days to switch patients to the new medication, with dose adjustments made every 2–3 days[4].

Market Analysis

Prescription Trends

Hydromorphone, like other opioids, has seen fluctuations in prescription trends. According to the CDC, the release of the 2016 Opioid Prescribing Guideline led to decreased overall opioid prescribing and a shift towards nonopioid pain medications. However, hydromorphone remains a significant player in the opioid market, particularly for moderate to severe pain management[3].

Abuse and Diversion

Despite its therapeutic benefits, hydromorphone has a high abuse and dependence potential. The DEA reports that hydromorphone diversion includes forged prescriptions, "doctor-shoppers," and robberies of pharmacies and nursing homes. The street price of a 4 mg tablet of Dilaudid can range from $5 to $100 per tablet, depending on the region[2].

Market Availability and Shortages

The market availability of hydromorphone products has faced challenges. For instance, the Dilaudid hydromorphone 1 mg/mL oral liquid was discontinued in August 2021, but substitute overseas-registered brands are available. Additionally, Jurnista (hydromorphone) prolonged-release tablets were discontinued in April 2023, with alternatives available under the Special Access Scheme[5].

Market Projections

Demand and Supply Dynamics

Given the ongoing opioid crisis and regulatory changes, the demand for hydromorphone is expected to remain stable but with a focus on safer prescribing practices. The CDC's updated clinical practice guideline for prescribing opioids emphasizes evidence-based recommendations to minimize opioid-related risks, which may influence the prescribing patterns of hydromorphone[3].

Regulatory Environment

The regulatory environment continues to play a crucial role in the market dynamics of hydromorphone. As states implement laws limiting initial opioid prescriptions and promote nonopioid options for chronic pain, the market may see a shift towards more controlled and monitored use of opioids like hydromorphone[3].

Product Innovations and Alternatives

The discontinuation of certain hydromorphone products and the introduction of substitute brands suggest a dynamic market. For example, the availability of Ordine (morphine) oral liquid alternatives and the potential return to supply of other oral opioid products in 2025 indicate that manufacturers are adapting to market needs and regulatory changes[5].

Economic Impact

Cost-Effectiveness

Studies have shown that supervised, medically prescribed diacetylmorphine (and by extension, hydromorphone as an alternative) can be cost-effective in treating opioid dependence. This cost-effectiveness, combined with the clinical efficacy, makes hydromorphone a viable option in healthcare settings where diacetylmorphine is not available[1].

Market Size and Growth

The opioid market, including hydromorphone, is significant but faces challenges due to regulatory and public health concerns. Despite these challenges, the market is expected to grow, albeit at a slower rate, as healthcare providers and policymakers seek balanced approaches to pain management and opioid use disorder treatment.

Patient and Healthcare Provider Perspectives

Patient Needs

Patients requiring moderate to severe pain management continue to rely on opioids like hydromorphone. The availability of various formulations (injectable, tablets, suppositories) and the development of extended-release preparations cater to different patient needs and preferences[2][4].

Healthcare Provider Considerations

Healthcare providers must navigate the complexities of opioid prescribing, balancing the need for effective pain management with the risk of abuse and dependence. The CDC's guidelines and other regulatory frameworks provide essential guidance for clinicians to make informed decisions about prescribing hydromorphone and other opioids[3].

Key Takeaways

  • Clinical Efficacy: Hydromorphone is as effective as diacetylmorphine in treating long-term opioid dependence and managing moderate to severe pain.
  • Market Trends: The market is influenced by regulatory changes, product discontinuations, and the introduction of substitute brands.
  • Regulatory Environment: Strict guidelines and laws aim to minimize opioid-related risks while ensuring access to necessary pain management options.
  • Economic Impact: Hydromorphone can be cost-effective in certain treatment scenarios, contributing to its market viability.
  • Patient and Provider Perspectives: Balancing effective pain management with the risk of abuse remains a critical challenge.

FAQs

What is Dilaudid (Hydromorphone) used for?

Dilaudid, or hydromorphone, is used for the relief of moderate to severe pain.

Is Hydromorphone effective in treating opioid dependence?

Yes, studies such as the SALOME trial have shown that hydromorphone is as effective as diacetylmorphine in treating long-term opioid dependence.

What are the common formulations of Hydromorphone?

Hydromorphone is available in various formulations, including injectable ampules, multiple dose vials, tablets, and suppositories[2].

Why has there been a shortage of certain Hydromorphone products?

There have been discontinuations and supply issues with certain hydromorphone products, such as the Dilaudid oral liquid and Jurnista prolonged-release tablets, but substitute brands are available[5].

How does the regulatory environment impact the market for Hydromorphone?

The regulatory environment, including guidelines and laws limiting opioid prescriptions, influences the market dynamics and prescribing patterns of hydromorphone[3].

Sources

  1. Hydromorphone Compared With Diacetylmorphine for Long-term Opioid Dependence. JAMA Psychiatry, 2016.
  2. Hydromorphone. Diversion Control Division, Drug & Chemical Evaluation Section.
  3. CDC Clinical Practice Guideline for Prescribing Opioids for Pain. CDC, 2022.
  4. Hydromorphone. Journal of Pain and Symptom Management.
  5. About the shortage and discontinuation of oral opioid products. Therapeutic Goods Administration (TGA).

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