Nalmefene hydrochloride

DRUG5 trials

Sponsors

Otsuka Pharmaceutical Co., Ltd., Opiant Pharmaceuticals Inc

Conditions

Alcohol DependenceOpioid OverdosePharmacodynamicPharmacokinetics

Phase 1

Pharmacokinetic Evaluation of Intranasal Nalmefene

CompletedNCT04759768

Opiant Pharmaceuticals IncPharmacokinetics

Start: 2021-02-08End: 2021-05-24Updated: 2024-08-13

Pharmacodynamic Evaluation of Intranasal Nalmefene

CompletedNCT04828005

Opiant Pharmaceuticals IncPharmacodynamic

Start: 2021-03-30End: 2022-03-14Updated: 2025-07-14

Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens

CompletedNCT05219669

Opiant Pharmaceuticals IncOpioid Overdose

Start: 2021-09-01End: 2021-11-22Updated: 2024-08-05

Phase 3

A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-parallel-group Comparison Trial to Investigate the Effect of Nalmefene on Alcohol Consumption Reduction in Patients With Alcohol Dependence (Phase 3 Trial)

CompletedNCT02364947

Otsuka Pharmaceutical Co., Ltd.Alcohol Dependence

Start: 2015-02-09End: 2016-07-30Updated: 2019-09-30

A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence

CompletedNCT02382276

Otsuka Pharmaceutical Co., Ltd.Alcohol Dependence

Start: 2015-07-13End: 2017-01-18Updated: 2020-07-20

Related Papers

Reversal of Opioid-Induced Respiratory Depression in Healthy Volunteers: Comparison of Intranasal Nalmefene and Intranasal Naloxone.

2024-03-0413 citations

Pharmacokinetic Properties of an FDA‐approved Intranasal Nalmefene Formulation for the Treatment of Opioid Overdose

Clinical Pharmacology in Drug Development2023-07-2727 citations