CLINICAL TRIALS PROFILE FOR NALOXONE HYDROCHLORIDE

505(b)(2) Clinical Trials for NALOXONE HYDROCHLORIDE

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	NCT02137213 ↗	Feasibility Study of Oral Naloxone for Treatment of Methadone-induced Constipation	Completed	Academic Health Science Centres	Phase 2	2014-08-01	At least 30% of patients receiving methadone maintenance therapy (MMT) are suffering from constipation that often affects effectiveness of MMT and increases its impact on health care system. Existing treatments include several over-the-counter medications which do not target the pathobiological basis of opioid-induced constipation and have limited effectiveness. At the same time well-known medication, naloxone, was already shown to help with constipation in patients receiving methadone for chronic pain, but was never tried in patients receiving methadone for opioid dependence. This study is aimed to try naloxone for treatment of opioid-induced constipation in MMT settings. The investigators will enroll 20 patients receiving MMT and suffering from opioid-induced constipation. The study has a crossover design - all patients will receive one week of their regular methadone doses and one week of their regular methadone doses with naloxone added. Normal saline will be added to methadone-only formulations as placebo. Order of the weeks will be chosen randomly. Both subjects and investigators will be blinded to the study condition (i.e. whether naloxone or normal saline is added to methadone preparation on a given week). Primary hypothesis: Patients receiving combination of oral methadone/naloxone in ratio 50:1 will have less severe symptoms of constipation compared to those receiving methadone only. Secondary hypothesis: Addition of oral naloxone to methadone in a ratio 50:1 will not cause clinically significant opioid withdrawal symptoms.
OTC	NCT02137213 ↗	Feasibility Study of Oral Naloxone for Treatment of Methadone-induced Constipation	Completed	Centre for Addiction and Mental Health	Phase 2	2014-08-01	At least 30% of patients receiving methadone maintenance therapy (MMT) are suffering from constipation that often affects effectiveness of MMT and increases its impact on health care system. Existing treatments include several over-the-counter medications which do not target the pathobiological basis of opioid-induced constipation and have limited effectiveness. At the same time well-known medication, naloxone, was already shown to help with constipation in patients receiving methadone for chronic pain, but was never tried in patients receiving methadone for opioid dependence. This study is aimed to try naloxone for treatment of opioid-induced constipation in MMT settings. The investigators will enroll 20 patients receiving MMT and suffering from opioid-induced constipation. The study has a crossover design - all patients will receive one week of their regular methadone doses and one week of their regular methadone doses with naloxone added. Normal saline will be added to methadone-only formulations as placebo. Order of the weeks will be chosen randomly. Both subjects and investigators will be blinded to the study condition (i.e. whether naloxone or normal saline is added to methadone preparation on a given week). Primary hypothesis: Patients receiving combination of oral methadone/naloxone in ratio 50:1 will have less severe symptoms of constipation compared to those receiving methadone only. Secondary hypothesis: Addition of oral naloxone to methadone in a ratio 50:1 will not cause clinically significant opioid withdrawal symptoms.
New Formulation	NCT02158117 ↗	Bioavailability of a New Formulation of Nasal Naloxone for Prehospital Use	Completed	St. Olavs Hospital	Phase 1	2014-03-01	Overdose with potential deadly outcome is a serious problem among opioid abusers, not least in Norway. The annual death toll from overdose is about 250, twice the annual death toll from traffic accidents. Those who inject heroin or other opioids are considered to have the highest risk for death from overdose. To save lives, immediate treatment with a μ-opioid antidote such as naloxone is required. Usually naloxone is injected into a muscle or a blood vessel. Administration of naloxone via the nose has been suggested as an alternative for use by emergency teams and possibly also bystanders. This is not only an easier way to give naloxone, but would also eliminate the risk for needle stick injuries and blood contamination. A pilot study in this hospital has shown no significant side effects or adverse reaction. While significant benefits are expected from developing an adequately formulated naloxone nasal spray for pre-hospital use, the risks to participants are minimal. Therefore this preclinical study in healthy volunteers will be undertaken.
New Formulation	NCT00637000 ↗	Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone	Completed	Indivior Inc.	Phase 2	2008-03-01	The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active opioid dependence. The primary outcome measure is the severity of withdrawal symptoms measured using the Clinical Opiate Withdrawal Scale (COWS). The primary study hypothesis is that neither drug formulation will precipitate an opioid withdrawal syndrome.

All Clinical Trials for NALOXONE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000192 ↗	Neurobiology of Opioid Dependence: 1 - 1	Withdrawn	National Institute on Drug Abuse (NIDA)	Phase 2	1993-01-01	The purpose of this study is to evaluate the effects of lamotrigine on naloxone-precipitated opiate withdrawal.
NCT00000192 ↗	Neurobiology of Opioid Dependence: 1 - 1	Withdrawn	Yale University	Phase 2	1993-01-01	The purpose of this study is to evaluate the effects of lamotrigine on naloxone-precipitated opiate withdrawal.
NCT00000193 ↗	Neurobiology of Opioid Dependence: 2 - 2	Withdrawn	National Institute on Drug Abuse (NIDA)	Phase 2	1993-01-01	The purpose of this study is to evaluate the effects of gamma hydroxybutyric on naloxone-precipitated opiate withdrawal.
NCT00000193 ↗	Neurobiology of Opioid Dependence: 2 - 2	Withdrawn	Yale University	Phase 2	1993-01-01	The purpose of this study is to evaluate the effects of gamma hydroxybutyric on naloxone-precipitated opiate withdrawal.

Clinical Trial Conditions for NALOXONE HYDROCHLORIDE

Condition Name

Condition Name for NALOXONE HYDROCHLORIDE
Intervention	Trials
Opioid-Related Disorders	40
Pain	29
Opioid Use Disorder	23
Opioid Dependence	21

Condition MeSH

Condition MeSH for NALOXONE HYDROCHLORIDE
Intervention	Trials
Opioid-Related Disorders	125
Substance-Related Disorders	35
Disease	20
Constipation	18

Clinical Trial Locations for NALOXONE HYDROCHLORIDE

Trials by Country

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Trials by Country for NALOXONE HYDROCHLORIDE
Location	Trials
United States	467
Canada	23
China	22
Norway	14
Germany	12

Trials by US State

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−

Trials by US State for NALOXONE HYDROCHLORIDE
Location	Trials
New York	42
Maryland	36
California	32
Massachusetts	22
Pennsylvania	19

Clinical Trial Progress for NALOXONE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for NALOXONE HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	85
Phase 3	55
Phase 2/Phase 3	11

Clinical Trial Status

Clinical Trial Status for NALOXONE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	206
Recruiting	42
Not yet recruiting	39

Clinical Trial Sponsors for NALOXONE HYDROCHLORIDE

Sponsor Name

Sponsor Name for NALOXONE HYDROCHLORIDE
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	66
Indivior Inc.	14
Johns Hopkins University	13

Sponsor Type

Sponsor Type for NALOXONE HYDROCHLORIDE
Sponsor	Trials
Other	340
Industry	124
NIH	79

Naloxone Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Naloxone Hydrochloride

Naloxone hydrochloride is a potent opioid antagonist used to reverse opioid overdose. Its importance has grown significantly in the context of the opioid epidemic, leading to extensive research, clinical trials, and market expansion.

Clinical Trials and Research

NIDA-Funded Research and FDA Approvals

NIDA-funded research has been instrumental in the development and approval of naloxone hydrochloride products. The first naloxone nasal spray, approved by the FDA in 2015, has been a crucial tool in reversing opioid overdoses. Recent research has also led to the FDA approval of a nasal spray formulation of nalmefene, another opioid-blocking agent, in 2023. Nalmefene offers a longer duration of action compared to naloxone, addressing the need for more sustained overdose reversal, especially with increasingly powerful opioids[1].

Opioid Associated Out of Hospital Cardiac Arrest (NOPACA)

An ongoing clinical trial, NOPACA, aims to determine the efficacy of naloxone in treating opioid-associated out-of-hospital cardiac arrest. This randomized, double-blind, controlled trial will assess whether early administration of naloxone by EMS personnel improves survival rates. The pilot study will evaluate feasibility, treatment fidelity, and retention rates to inform the design of a larger definitive trial[4].

Market Analysis

Market Size and Growth

The global naloxone hydrochloride market is projected to experience significant growth. As of 2022, the market was valued at approximately $1,118.3 million and is expected to grow at a CAGR of 10.4% until 2030, reaching an estimated value of $2,460.2 million[5].

Market Segmentation

The naloxone hydrochloride market is segmented based on type and application. The types include formulations with more than 98% and less than 98% purity, while applications include injections, tablets, and others. The majority of naloxone units are sold to non-retail settings such as hospitals, clinics, and institutions supplying first responders and emergency medical services[2][3].

Regional Analysis

The market is analyzed across various regions including North America, Europe, APAC, MEA, and South & Central America. Favorable reimbursement scenarios in developed regions like North America and Europe are expected to drive market growth. A comprehensive PEST analysis for these regions highlights the political, economic, social, and technological factors influencing the market[2].

Market Trends and Drivers

Increasing Research and Development

The market is driven by increasing research and development activities, particularly in the area of opioid overdose reversal. NIDA's support for therapies using psychedelic drugs and other opioid-blocking agents is expanding the treatment landscape[1].

Product Launches and Approvals

Recent approvals, such as the non-prescription versions of naloxone in 2023, and the introduction of new formulations like nalmefene, are key drivers of market growth. These developments are expected to increase accessibility and adoption of naloxone products[1][3].

Over-the-Counter (OTC) Status

The FDA's move to develop and validate model Drug Facts Labels for OTC naloxone products is a significant trend. This could lead to increased sales and wider distribution, making naloxone more accessible to the general public. However, it also raises questions about potential changes in supply and demand dynamics and pricing strategies[3].

Cost-Effectiveness and Distribution Strategies

Community and Pharmacy Distribution

Studies have shown that wider distribution of naloxone, especially to people who use drugs, can reduce community overdose rates. Strategies involving community, pharmacy, and other health settings have been effective in increasing access to naloxone. Despite the small market size, estimated at around $290 million in annual sales, the impact of these strategies is substantial[3].

Economic Impact

The cost-effectiveness of naloxone distribution has been a focus of recent analyses. For instance, a study by CHERISH investigators modeled the supply and demand factors to predict the effects of converting naloxone to OTC status, highlighting potential economic benefits and challenges[3].

Future Projections

Market Growth Projections

The global naloxone hydrochloride market is expected to continue its growth trajectory, driven by favorable reimbursement scenarios, increasing research and development, and new product launches. The projected CAGR of 10.4% from 2022 to 2030 indicates a robust market with significant potential for expansion[5].

Regulatory and Policy Changes

Future growth will also be influenced by regulatory and policy changes, such as the potential for more OTC approvals and expanded distribution strategies. These changes are likely to increase accessibility and reduce overdose rates, further driving market demand[3].

Key Takeaways

• Clinical Trials: Ongoing trials like NOPACA are crucial for understanding the efficacy of naloxone in specific scenarios, such as out-of-hospital cardiac arrest.
• Market Growth: The global naloxone hydrochloride market is projected to grow significantly, driven by research, new product approvals, and favorable reimbursement scenarios.
• Distribution Strategies: Wider distribution, including OTC status, is expected to increase accessibility and reduce overdose rates.
• Economic Impact: Cost-effectiveness studies and economic analyses are essential for understanding the broader impact of naloxone distribution strategies.

FAQs

What is the current market size of the naloxone hydrochloride market?

The global naloxone hydrochloride market was valued at approximately $1,118.3 million in 2022[5].

What is the projected growth rate of the naloxone hydrochloride market?

The market is expected to grow at a CAGR of 10.4% from 2022 to 2030[5].

What are the main types of naloxone hydrochloride products available?

Naloxone hydrochloride products include injection formulations, auto-injectors, and nasal sprays[3].

How has NIDA-funded research impacted the development of naloxone products?

NIDA-funded research has led to the development and FDA approval of several naloxone products, including the first naloxone nasal spray and recent approvals for non-prescription versions and nalmefene formulations[1].

What is the significance of the NOPACA clinical trial?

The NOPACA trial aims to determine the efficacy of naloxone in treating opioid-associated out-of-hospital cardiac arrest, which could save thousands of lives annually in the context of the opioid epidemic[4].

Sources

1. NIDA FY 2025 narrative - NIDA-funded research led to the first naloxone nasal spray, approved by the FDA in 2015 as an effective medication to reverse opioid overdose.
2. The Insight Partners - Naloxone Hydrochloride Market Insights and Growth by 2031.
3. LDI at Penn - Expanding Access to Naloxone: A Review of Distribution Strategies.
4. UCSF Clinical Trials - Naloxone for Opioid Associated Out of Hospital Cardiac Arrest.
5. GlobeNewswire - Global Naloxone Market to surpass US$ 2,460.2 Million by 2030, Says Coherent Market Insights (CMI).