Nalmefene for reduction of alcohol consumption in specific target populations

a technology of specific target populations and nalmefene, which is applied in the direction of biocide, heterocyclic compound active ingredients, drug compositions, etc., can solve the problems of adverse social consequences, increased risk of health-related harm, and high levels of alcohol consumption

Inactive Publication Date: 2014-01-02
H LUNDBECK AS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Based on independent evidence, high levels of alcohol consumption are associated with an increased risk of health-related harm, as well as adverse social consequences.

Method used

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  • Nalmefene for reduction of alcohol consumption in specific target populations
  • Nalmefene for reduction of alcohol consumption in specific target populations
  • Nalmefene for reduction of alcohol consumption in specific target populations

Examples

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examples

[0226]The invention will be illustrated by the following non-limiting examples.

[0227]The efficacy of nalmefene on the reduction of alcohol consumption in patients with alcohol dependence (DSM-IV) was evaluated in two efficacy studies (Study 12014A and Study 12023A). Both studies were randomised, double blind, two-parallel group, placebo controlled, and after 6 months of treatment, patients receiving nalmefene were re-randomised to receive either placebo or nalmefene in a 1 month run out period. The efficacy of nalmefene was also evaluated in a randomised, double blind, two parallel group, placebo controlled 1 year safety study (Study 12013A). The studies included 1941 patients, 1144 of whom were treated with nalmefene 18 mg in an as-needed dosing regimen.

[0228]The studies were conducted applying an outpatient setting without preceding detoxification. Higher CIWA withdrawal scores (Clinical Institute Withdrawal Assessment for Alcohol) at screening as well as a history of delirium tre...

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Abstract

The present invention relates to nalmefene for use in the reduction of alcohol consumption in a patient with alcohol dependence who has a high drinking risk level. The present invention also relates to nalmefene for use in the reduction of alcohol consumption in a patient with alcohol dependence who maintains a high DRL after an observation period following initial assessment.

Description

FIELD OF THE INVENTION[0001]The present invention relates to nalmefene for use in the reduction of alcohol consumption in a patient with alcohol dependence who has a high drinking risk level. The present invention also relates to nalmefene for use in the reduction of alcohol consumption in a patient with alcohol dependence who maintains a high DRL after an observation period following initial assessment.BACKGROUND OF THE INVENTION[0002]Nalmefene [17-(cyclopropylmethyl)-4,5-alpha-epoxy-6-methylenemorphinan-3,14-diol] has the following general formula:and can be prepared using methods that are well known in the art e.g. starting by manufacturing of naltrexone from noroxmorphone as described in WO 2012 / 059103 and subsequently manufacturing nalmefene from naltrexone e.g. by the Wittig reaction as described in WO 2010 / 136039. The entire contents of each of WO 2012 / 059103 and WO 2010 / 136039 are incorporated herein by reference.[0003]Nalmefene is a known opioid system modulator, with a dis...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/485
CPCA61K31/485A61P25/00A61P25/32A61P43/00A61K9/0053A61K9/20A61K9/48
Inventor TORUP, LARSABBARIKI, AFSANEHBLADSTROM, ANNAPERSSON, CHRISTINEMEULIEN, DIDIERSORENSEN, PERJENSEN, THOMAS JONOSTERGAARD, JETTE BUCH
Owner H LUNDBECK AS
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