Trial Profile

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)

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 07 Dec 2021

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At a glance

02 May 2020 Results published in the Psychiatry and Clinical Neurosciences
08 Jan 2019 According to an Otsuka Pharmaceutical media release, the company has received regulatory approval in Japan for the manufacture and sale of Selincro Tablets 10 mg (nalmefene hydrochloride), as a treatment to reduce alcohol consumption in alcohol-dependent patients.
17 Oct 2017 Primary endpoint has been met. (Change in the number of Heavy Drinking Days (HDDs) from baseline), according to an Otsuka Pharmaceutical media release.

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