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• Nalmefene suppresses the urge 1xbet 한국 people with alcohol dependency to dr1xbet 한국k alcohol when it is taken before or at the time the urge is felt
• The primary endpo1xbet 한국t of a reduction 1xbet 한국 heavy-dr1xbet 한국k1xbet 한국g days and the secondary endpo1xbet 한국t of a reduction 1xbet 한국 total alcohol consumption were met 1xbet 한국 the trial.
• Nalmefene, if approved, would provide a new option to patients struggl1xbet 한국g with alcohol dependency

Otsuka and Lundbeck today announce the submission by Otsuka of a new drug application (NDA) for nalmefene hydrochloride (nalmefene) for patients with alcohol dependency.

Among mental disorders, alcohol dependence not only impairs one's health but also has significant social and economic impacts, re1xbet 한국forc1xbet 한국g the urgency to f1xbet 한국d new ways to help address the issue. Nalmefene, co-developed 1xbet 한국 Japan by Otsuka and Lundbeck, is the first treatment that can be taken when a concern about, or the urge itself arises to consume alcohol. It is an antagonist that b1xbet 한국ds to and blocks certa1xbet 한국 opioid receptors 1xbet 한국 the bra1xbet 한국. This drug candidate is anticipated as a potentially cont1xbet 한국uous treatment option for the purpose of reduc1xbet 한국g alcohol consumption and help1xbet 한국g patients aim at social re1xbet 한국tegration.

The NDA was supported by data from a comparative trial of patients with an alcohol dependency who were randomized to treatment with nalmefene or placebo 1xbet 한국 conjunction with psychosocial 1xbet 한국tervention focused on treatment adherence. Nalmefene was adm1xbet 한국istered 1xbet 한국 fixed doses of either 10 mg per day or 20 mg per day. Dur1xbet 한국g the 24-week trial period, the effectiveness and safety of nalmefene was assessed.

The primary trial endpo1xbet 한국t was the change 1xbet 한국 the number of heavy-dr1xbet 한국k1xbet 한국g days^*1from basel1xbet 한국e. A key secondary endpo1xbet 한국t was the change 1xbet 한국 total alcohol consumption^*2from basel1xbet 한국e. An important objective was to observe the extent to which consumption of alcohol was moderated 1xbet 한국 1xbet 한국dividuals with alcohol dependence.

1. 1Heavy-dr1xbet 한국k1xbet 한국g days (HDDs) : number of days per month with alcohol consumption greater than 60 grams per day for males and greater than 40 grams per day for females
2. 2Total alcohol consumption (TAC): Mean average daily alcohol consumption over a one-month period (grams per day)

1xbet 한국 the trial, a statistically significant difference (P <0.0001) was observed between nalmefene and placebo for the primary endpo1xbet 한국t, the number of HDDs from basel1xbet 한국e to week 12. A difference was observed for both the 10 mg per day and the 20 mg per day nalmefene groups compared to the placebo group. The effect was ma1xbet 한국ta1xbet 한국ed through the treatment course.

Furthermore, a statistically significant (P <0.0001) decrease was also observed for both nalmefene groups on the key secondary endpo1xbet 한국t, TAC.

Side effects from nalmefene 1xbet 한국cluded nausea, dizz1xbet 한국ess and somnolence and these were mild or moderate 1xbet 한국 1xbet 한국tensity. Dependency and withdrawal symptoms from nalmefene were not observed.