CLINICAL TRIALS PROFILE FOR NALOXONE

505(b)(2) Clinical Trials for NALOXONE

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
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.
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	NCT02158117 ↗	Bioavailability of a New Formulation of Nasal Naloxone for Prehospital Use	Completed	Norwegian University of Science and Technology	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.

All Clinical Trials for NALOXONE

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.
NCT00000194 ↗	Neurobiology of Opioid Dependence: 3 - 3	Withdrawn	National Institute on Drug Abuse (NIDA)	Phase 2	1993-01-01	The purpose of this study is to study the effects of cycloserine on naloxone-precipitated opiate withdrawal.

Clinical Trial Conditions for NALOXONE

Condition Name

Condition Name for NALOXONE
Intervention	Trials
Opioid-Related Disorders	41
Pain	29
Opioid Use Disorder	27
Opioid Dependence	21

Condition MeSH

Condition MeSH for NALOXONE
Intervention	Trials
Opioid-Related Disorders	130
Substance-Related Disorders	36
Disease	20
Pain, Postoperative	18

Clinical Trial Locations for NALOXONE

Trials by Country

Trials by Country for NALOXONE
Location	Trials
United States	491
China	24
Canada	23
Norway	14
Germany	12

Trials by US State

Trials by US State for NALOXONE
Location	Trials
New York	43
California	37
Maryland	37
Massachusetts	23
Pennsylvania	19

Clinical Trial Progress for NALOXONE

Clinical Trial Phase

Clinical Trial Phase for NALOXONE
Clinical Trial Phase	Trials
PHASE4	8
PHASE3	5
PHASE2	3

Clinical Trial Status

Clinical Trial Status for NALOXONE
Clinical Trial Phase	Trials
Completed	211
Recruiting	51
Not yet recruiting	39

Clinical Trial Sponsors for NALOXONE

Sponsor Name

Sponsor Name for NALOXONE
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	70
Indivior Inc.	14
Johns Hopkins University	13

Sponsor Type

Sponsor Type for NALOXONE
Sponsor	Trials
Other	368
Industry	131
NIH	84

NALOXONE Market Analysis and Financial Projection

Last updated: April 29, 2026

Naloxone: Clinical Trials Update, Market Analysis, and Price-Volume Projection

Naloxone is an opioid antagonist used to reverse opioid-induced respiratory depression. The clinical development landscape is dominated by line extensions (new formulations, routes, dosing devices, and combination products) rather than late-stage breakthrough efficacy programs. Commercially, naloxone is a mature, high-penetration product category driven by public-health purchasing, first-responder adoption, and payer/coverage policies. Growth continues through device-led expansion (nasal and auto-injector formats) and broader procurement mandates.

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What clinical trials define naloxone’s current development?

Trial activity: what is still being tested

Recent clinical work for naloxone has focused on four themes:

• Alternative routes and formulations (especially intranasal and autoinjector presentations) to improve usability and time-to-treatment.
• Population and setting expansion (community use, EMS workflows, pediatric considerations).
• Device usability endpoints (recognition, correct administration rates, time to administration).
• Comparative pharmacokinetics and exposure equivalence across formulations and delivery systems.

Because naloxone’s mechanism and core clinical endpoint (reversal of opioid-induced respiratory depression) are well-established, many programs use smaller, targeted studies rather than large, mortality-powered trials.

Regulatory and evidence anchor

Naloxone’s clinical evidence base includes both controlled studies and extensive real-world use. FDA labeling supports naloxone dosing and administration principles that have become standard for opioid reversal workflows [1].

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What is the current product and regulatory landscape?

Approved naloxone presentations that matter commercially

Naloxone is sold in multiple formats:

• Intranasal products (notably ready-to-use sprays).
• Injectables (including prefilled syringes and ampules used by EMS and hospitals).
• Auto-injectors in some markets and channels.

In practice, the procurement mix depends on budget, training infrastructure, and contract preferences with government and payers.

Label dosing baseline

FDA labeling for naloxone products defines typical adult dosing and repeat dosing guidance when opioid effect recurs [1]. This label consistency reduces clinical switching risk for payers and procurement agencies, which supports market scaling of additional branded and generic versions.

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How does the market size and growth profile look for naloxone?

Demand drivers that determine volume

Naloxone demand is tied to institutional and policy-driven purchasing rather than patient-initiated demand.

Key drivers include:

• Public-health and harm-reduction programs (distribution through community organizations and first-responder kits).
• EMS and hospital stock expansion for opioid overdose response readiness.
• Workplace and school policies in certain jurisdictions requiring or incentivizing availability.
• Coverage and reimbursement frameworks that determine patient access for take-home naloxone (varies by country and payer structure).

Competitive structure

The market has two overlapping segments:

1. Institutional/EMS procurement

   • Price and contract terms dominate.
   • Training and device workflow compatibility matter.

2. Community take-home

   • Device simplicity and instructions drive conversion.
   • Product familiarity and pack format influence adoption.

Price discipline versus device premium

• Injectable and generic intranasal face stronger price pressure.
• Device-led, ready-to-use formats tend to sustain higher net prices due to reduced administration complexity and procurement preferences.

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What is the projection: price-volume outlook and scenarios?

Projection framework

Naloxone growth is modeled as:

• Volume growth from continued program expansion and replenishment cycles.
• Price per unit growth from mix shift toward device formats and periodic contract repricing, partially offset by generic entry and competitive tendering.

Scenario ranges (directional, for investment planning)

Given naloxone’s maturity and policy dependence, the base case uses conservative assumptions: volume expands steadily; price is flat to modestly down overall, with device-mix lift keeping intranasal and auto-injector nets above injectables.

Base case (steady policy adoption)

• Volume: low-to-mid single-digit annual growth (replenishment + incremental adoption).
• Price (blended): flat to slightly declining, driven by generic intranasal and tendering pressure, offset by device-mix.
• Revenue: grows broadly in line with volume, with limited margin expansion.

Upside case (accelerated adoption via mandates and payer coverage)

• Volume: higher single-digit to low-teens annual growth driven by mandated availability and broader take-home programs.
• Price: modestly supported by device mix and contract preferences; still constrained by generic substitution.
• Revenue: faster than volume due to mix shift (higher-value device formats).

Downside case (procurement tightening)

• Volume: mid-to-low single-digit growth due to budget constraints and slower program rollout.
• Price: declines faster due to larger generic intranasal share and aggressive tender pricing.
• Revenue: below base case due to both volume and price pressure.

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Where do clinical outcomes connect to commercial performance?

Usability endpoints drive adoption

For naloxone, the commercial selection criteria often hinge on administration practicality:

• faster correct administration
• clarity of instructions
• reduced training burden
• confidence in correct device operation by non-medical users

Even when pharmacologic reversal is unchanged, improved usability changes procurement decisions and increases take-home adoption.

Switching risk is low because efficacy and dosing are standardized

Label-based dosing and accepted clinical reversal endpoints reduce the barrier to switching between products within the same route category. That lowers customer lock-in and increases the importance of price competitiveness and device reliability.

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Key commercialization constraints and risks

• Tender-driven pricing compresses margins in institutional channels.
• Generic substitution caps branded pricing power, especially for injectables and lower-spec intranasal products.
• Device reliability perceptions affect adoption; post-market issues can quickly change procurement behavior.
• Policy variability across jurisdictions can cause uneven demand timing.

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Key takeaways

• Naloxone’s clinical development is dominated by formulation and device extensions rather than new mechanism-of-action efficacy breakthroughs.
• Market demand is policy and procurement-led with repeat replenishment cycles, which supports stable volume growth.
• Blended pricing is constrained by generic competition and tendering, while device-format mix supports net price stabilization for intranasal/auto-injector categories.
• Base-case revenue growth is volume-led with limited pricing upside; upside comes from accelerated mandates and payer coverage expanding take-home access.

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FAQs

1) Does naloxone still have meaningful late-stage clinical upside?

Development is largely incremental, with late-stage programs usually focused on formulation equivalence, usability, and workflow endpoints rather than new clinical outcome frontiers.

2) What route typically wins procurement decisions?

The winner depends on setting. EMS and hospitals may prefer injectable formats for workflow control, while take-home programs often prefer ready-to-use intranasal or auto-injector devices for usability.

3) How sensitive is the naloxone market to reimbursement changes?

High. Take-home and community programs depend on payer coverage rules and reimbursement policy design, which can shift volume between institutional-only and broader patient access models.

4) How do generics affect branded naloxone profitability?

They usually compress pricing in tender and replenishment cycles, forcing branded products to compete on device usability, supply reliability, and contract-specific terms.

5) What is the most important commercial determinant for new naloxone entrants?

Adoption friction: time-to-correct use, training requirements, and contract fit. Clinical efficacy differentiation is limited because core reversal biology is established.

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References

[1] U.S. Food and Drug Administration. (n.d.). NARCAN (naloxone hydrochloride) nasal spray prescribing information and related FDA labeling for naloxone products. FDA. https://www.accessdata.fda.gov/ (accessed via FDA label database)