Long-term safety and efficacy of nalmefene in Japanese patients with alcohol dependence.

ABSTRACT:

Aim

The safety and efficacy of nalmefene in Japanese patients with high or very high World Health Organization drinking risk level of alcohol dependence were assessed in a multicenter, randomized, double-blind, placebo-controlled, phase 3 (lead-in) study. Here, the long-term safety and efficacy of nalmefene in an open-label extension of the lead-in study are presented.

Methods

Patients who completed the 24-week lead-in study were eligible for the extension study, where they were treated with nalmefene 20 mg as needed for 24 weeks. The long-term safety and efficacy of nalmefene 20 mg during the total 48-week period were evaluated. Treatment-emergent adverse events during the study period were recorded and change from baseline in the number of heavy drinking days and total alc

SUBMITTER: Higuchi S 

PROVIDER: S-EPMC7496902 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature