Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
McKesson
Medtronic
McKinsey
AstraZeneca

Last Updated: November 18, 2019

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR NALOXONE HYDROCHLORIDE

See Plans and Pricing

« Back to Dashboard

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
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.
New Formulation NCT02307721 Pharmacokinetics and Pharmacodynamics of a New Formulation of Nasal Naloxone for Prehospital Use Completed St. Olavs Hospital Phase 1/Phase 2 2014-12-01 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, higher than road 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 (intranasal) 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. In a series of studies on intranasal naloxone at The Norwegian University of Science and Technology, this study explores pharmacokinetics and pharmacodynamics of intranasal and intramuscular naloxone in healthy volunteers under the influence of remifentanil.
New Formulation NCT02307721 Pharmacokinetics and Pharmacodynamics of a New Formulation of Nasal Naloxone for Prehospital Use Completed Norwegian University of Science and Technology Phase 1/Phase 2 2014-12-01 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, higher than road 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 (intranasal) 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. In a series of studies on intranasal naloxone at The Norwegian University of Science and Technology, this study explores pharmacokinetics and pharmacodynamics of intranasal and intramuscular naloxone in healthy volunteers under the influence of remifentanil.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
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.
NCT00000194 Neurobiology of Opioid Dependence: 3 - 3 Withdrawn Yale University Phase 2 1993-01-01 The purpose of this study is to study the effects of cycloserine on naloxone-precipitated opiate withdrawal.
NCT00000243 Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone Terminated National Institute on Drug Abuse (NIDA) N/A 2002-09-01 Buprenorphine is a drug that may be helpful in treating opioid dependent individuals who were previously maintained on methadone. The purpose of this study is to determine the effects of different doses of buprenorphine/naloxone in treating opioid dependent individuals who were previously maintained on methadone.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Naloxone Hydrochloride

Condition Name

Condition Name for Naloxone Hydrochloride
Intervention Trials
Opioid-Related Disorders 37
Pain 25
Opioid Dependence 16
Heroin Dependence 14
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Condition MeSH

Condition MeSH for Naloxone Hydrochloride
Intervention Trials
Opioid-Related Disorders 59
Constipation 17
Substance-Related Disorders 16
Drug Overdose 15
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Locations for Naloxone Hydrochloride

Trials by Country

Trials by Country for Naloxone Hydrochloride
Location Trials
United States 356
China 21
Canada 17
Norway 13
Finland 11
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Trials by US State

Trials by US State for Naloxone Hydrochloride
Location Trials
New York 34
California 26
Maryland 24
Texas 16
Florida 15
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Progress for Naloxone Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Naloxone Hydrochloride
Clinical Trial Phase Trials
Phase 4 59
Phase 3 47
Phase 2/Phase 3 8
[disabled in preview] 146
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Status

Clinical Trial Status for Naloxone Hydrochloride
Clinical Trial Phase Trials
Completed 143
Recruiting 39
Not yet recruiting 33
[disabled in preview] 46
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Sponsors for Naloxone Hydrochloride

Sponsor Name

Sponsor Name for Naloxone Hydrochloride
Sponsor Trials
National Institute on Drug Abuse (NIDA) 49
Indivior Inc. 12
Mundipharma Research GmbH & Co KG 12
[disabled in preview] 28
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Sponsor Type

Sponsor Type for Naloxone Hydrochloride
Sponsor Trials
Other 219
Industry 95
NIH 58
[disabled in preview] 7
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
Mallinckrodt
McKesson
McKinsey
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.