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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR EXALGO


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All Clinical Trials for Exalgo

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01207596 ↗ Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain Completed International Clinical Research Institute Phase 4 2010-09-01 The purpose of this study is to find out if Exalgo (r) is beneficial for the patients with neuropathic pain.
NCT01455519 ↗ True Functional Restoration and Analgesia in Non-Radicular Low Back Pain Completed Mallinckrodt Phase 4 2011-10-01 You are asked to take part in this study because you have chronic, non-radicular low back pain. This study is done to investigate the pain relieving effects of the study drug Exalgo (Hydromorphone ER) for people who experience chronic non-radicular low back pain. The purpose of this research is to look at how the study drug can be used to benefit people who experience this type of pain. This is a phase IV study done to study the safety and effectiveness of the drug. At this point the drug has been approved by the Food and Drug Administration and has been studied in more than 2,000 pain patients in clinical trials, including individuals with low back pain. About 36 subjects will take part in this study.
NCT01455519 ↗ True Functional Restoration and Analgesia in Non-Radicular Low Back Pain Completed Rehabilitation Institute of Chicago Phase 4 2011-10-01 You are asked to take part in this study because you have chronic, non-radicular low back pain. This study is done to investigate the pain relieving effects of the study drug Exalgo (Hydromorphone ER) for people who experience chronic non-radicular low back pain. The purpose of this research is to look at how the study drug can be used to benefit people who experience this type of pain. This is a phase IV study done to study the safety and effectiveness of the drug. At this point the drug has been approved by the Food and Drug Administration and has been studied in more than 2,000 pain patients in clinical trials, including individuals with low back pain. About 36 subjects will take part in this study.
NCT01455519 ↗ True Functional Restoration and Analgesia in Non-Radicular Low Back Pain Completed Shirley Ryan AbilityLab Phase 4 2011-10-01 You are asked to take part in this study because you have chronic, non-radicular low back pain. This study is done to investigate the pain relieving effects of the study drug Exalgo (Hydromorphone ER) for people who experience chronic non-radicular low back pain. The purpose of this research is to look at how the study drug can be used to benefit people who experience this type of pain. This is a phase IV study done to study the safety and effectiveness of the drug. At this point the drug has been approved by the Food and Drug Administration and has been studied in more than 2,000 pain patients in clinical trials, including individuals with low back pain. About 36 subjects will take part in this study.
NCT01517295 ↗ Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients Completed International Clinical Research Institute Phase 4 2012-02-01 Objective is to evaluate the pharmacokinetics profile of hydrocodone's metabolite hydromorphone in patients who are taking hydrocodone on a routine basis for more than 3 months for chronic pain and correlate hydromorphone levels to their hydrocodone usage.
NCT01517295 ↗ Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients Completed Medtronic - MITG Phase 4 2012-02-01 Objective is to evaluate the pharmacokinetics profile of hydrocodone's metabolite hydromorphone in patients who are taking hydrocodone on a routine basis for more than 3 months for chronic pain and correlate hydromorphone levels to their hydrocodone usage.
NCT01517295 ↗ Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients Completed NEMA Research, Inc. Phase 4 2012-02-01 Objective is to evaluate the pharmacokinetics profile of hydrocodone's metabolite hydromorphone in patients who are taking hydrocodone on a routine basis for more than 3 months for chronic pain and correlate hydromorphone levels to their hydrocodone usage.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Exalgo

Condition Name

Condition Name for Exalgo
Intervention Trials
Pain 2
Hematopoietic and Lymphoid Cell Neoplasm 1
Sickle Cell Disease 1
Intraoperative Complication 1
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Condition MeSH

Condition MeSH for Exalgo
Intervention Trials
Bile Duct Diseases 1
Back Pain 1
Intraoperative Complications 1
Neuralgia 1
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Clinical Trial Locations for Exalgo

Trials by Country

Trials by Country for Exalgo
Location Trials
United States 10
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Trials by US State

Trials by US State for Exalgo
Location Trials
Texas 2
Kansas 2
California 1
Wisconsin 1
Ohio 1
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Clinical Trial Progress for Exalgo

Clinical Trial Phase

Clinical Trial Phase for Exalgo
Clinical Trial Phase Trials
Phase 4 4
Phase 3 3
Early Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Exalgo
Clinical Trial Phase Trials
Completed 5
Recruiting 2
Active, not recruiting 1
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Clinical Trial Sponsors for Exalgo

Sponsor Name

Sponsor Name for Exalgo
Sponsor Trials
National Cancer Institute (NCI) 3
International Clinical Research Institute 2
M.D. Anderson Cancer Center 2
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Sponsor Type

Sponsor Type for Exalgo
Sponsor Trials
Other 11
NIH 5
Industry 3
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Exalgo: Clinical Trials, Market Analysis, and Projections

Introduction to Exalgo

Exalgo, an extended-release formulation of hydromorphone, was approved by the FDA on March 1, 2010, for the management of moderate to severe chronic pain in opioid-tolerant patients. It utilizes the OROS (Osmotic [Controlled] Release Oral Delivery System) technology to deliver hydromorphone at a constant rate over a 24-hour period[4].

Clinical Trials and Efficacy

The efficacy of Exalgo was demonstrated through a pivotal clinical trial, a 12-week, multicenter, double-blind, placebo-controlled study with a randomized withdrawal design. This study involved patients with chronic low back pain and was conducted at dosage strengths of 8 to 64 mg once daily. The primary endpoint was the change from baseline to Week 12/Final Visit in weekly mean pain intensity scores, which showed statistical significance (p < 0.001)[1].

Key Findings

  • The trial supported the primary endpoint, and all secondary endpoints except for rescue medication use also supported the efficacy of Exalgo.
  • The adverse event profile was consistent with that of mu-opioid agonists, and no unexpected or unusual adverse events were reported.
  • The study used imputation methods such as Baseline Observation Carried Forward (BOCF), Screening Observation Carried Forward (SOCF), and Last Observation Carried Forward (LOCF) to handle discontinuations[1].

Risk and Safety Profile

Exalgo, like other opioids, carries a significant risk of abuse and misuse. The Controlled Substances Staff (CSS) review highlighted that hydromorphone has a high abuse potential, comparable or slightly higher than oxycodone. The CSS recommended a Risk Evaluation and Mitigation Strategy (REMS) program to mitigate these risks, which included a phased rollout of the product and limiting prescriptions to experts in pain management[3].

Risk Evaluation and Mitigation Strategy (REMS)

  • The Exalgo Alliance™ Program, proposed by the sponsor, is more stringent than the interim opioid REMS and includes measures to ensure the drug is prescribed by knowledgeable practitioners and to designated patient populations.
  • The program aims to minimize the incidence of adverse events associated with inappropriate patient selection, misuse, and overdose[3].

Market Analysis

While Exalgo itself is not a major player in the broader pharmaceutical market, its niche in the opioid-tolerant patient segment is significant. Here’s a broader market context that might influence its positioning:

Pain Management Market

The pain management market, particularly for chronic pain, is substantial and growing. However, the opioid crisis has led to increased scrutiny and regulatory measures, affecting the market dynamics.

Competitive Landscape

Exalgo competes with other extended-release opioids and pain management drugs. The market is highly regulated, and any new entrants or changes in existing products must adhere to stringent safety and efficacy standards.

Projections and Future Outlook

Given the specific indication for opioid-tolerant patients, Exalgo's market growth is tied to the management of chronic pain in this population.

Market Trends

  • The opioid market is under intense scrutiny due to abuse and misuse concerns. This has led to a shift towards more stringent prescribing practices and the development of abuse-deterrent formulations.
  • Despite these challenges, the demand for effective chronic pain management remains high, suggesting a stable market for drugs like Exalgo that are approved for this specific use[4].

Sales and Revenue Projections

While specific revenue projections for Exalgo are not readily available, the overall opioid market trends suggest that sales will be influenced by regulatory environments and prescribing practices. The emphasis on REMS programs and strict prescribing guidelines will likely impact the growth trajectory of Exalgo.

Challenges and Opportunities

Regulatory Challenges

  • The high abuse potential of Exalgo necessitates strict regulatory oversight, which can limit its market expansion.
  • The REMS program and phased rollout strategy are critical in managing these risks but also add complexity to the marketing and distribution process[3].

Opportunities in Chronic Pain Management

  • The ongoing need for effective chronic pain management presents an opportunity for Exalgo to maintain its market presence.
  • Innovations in delivery systems and formulations that reduce abuse potential could further enhance its market position.

Pediatric Studies and Future Research

Exalgo's pediatric plan includes Phase 1 pharmacokinetic studies in children aged 7-17 and 2-<7 who are opioid-tolerant with chronic pain. These studies are part of the post-marketing commitments and will provide valuable data on the safety and efficacy of Exalgo in pediatric populations[1].

Key Takeaways

  • Exalgo is an effective extended-release formulation of hydromorphone for managing moderate to severe chronic pain in opioid-tolerant patients.
  • The drug has a high abuse potential, necessitating a stringent REMS program.
  • Market growth is influenced by regulatory environments and the ongoing need for effective chronic pain management.
  • Future research includes pediatric studies to expand the drug's use.

Frequently Asked Questions (FAQs)

What is Exalgo used for?

Exalgo is used for the management of moderate to severe chronic pain in opioid-tolerant patients. It is not indicated for acute pain or post-operative pain[4].

How does Exalgo work?

Exalgo uses the OROS technology to deliver hydromorphone at a constant rate over a 24-hour period, providing sustained pain relief[4].

What are the risks associated with Exalgo?

Exalgo carries a high risk of abuse and misuse, similar to other opioids. It also has risks associated with gastrointestinal obstruction and bezoar formation due to its extended-release formulation[1][3].

What is the REMS program for Exalgo?

The REMS program for Exalgo includes a phased rollout, limiting prescriptions to experts in pain management, and ensuring that the drug is prescribed only to designated patient populations to minimize risks of abuse and misuse[3].

Are there any ongoing studies for Exalgo?

Yes, there are ongoing pediatric studies to evaluate the safety and efficacy of Exalgo in children aged 7-17 and 2-<7 who are opioid-tolerant with chronic pain[1].

Cited Sources:

  1. FDA Medication Approval Document: "21-217s000 - Exalgo (Hydromorphone extended release)"[1].
  2. GlobalData Market Analysis: "NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025"[2].
  3. FDA Risk Evaluation and Mitigation Strategy: "21-217s000 - Exalgo (Hydromorphone extended release)"[3].
  4. Cleveland Clinic Center for Continuing Education: "In This Issue - Clinical Rx Forum"[4].

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