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
Price :
$35
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At a glance
- Drugs Nalmefene (Primary)
- Indications Alcoholism
- Focus Registrational; Therapeutic Use
- Sponsors Otsuka Pharmaceutical
- 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.