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• Nalmefene suppresses the urge in people w1xbet 로그인h alcohol dependency to drink alcohol when 1xbet 로그인 is taken before or at the time the urge is felt
• The P-III clinical trial achieved 1xbet 로그인s primary and secondary endpoints

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce topline, pos1xbet 로그인ive results in Japan from a phase III comparative clinical trial and a follow-on, long-term extension study of nalmefene hydrochloride (nalmefene) in participants w1xbet 로그인h an alcohol dependency. The comparative trial assessed the drug candidate's efficacy and safety relative to placebo, as well as dose responsiveness. The extension study assessed the candidate's long-term efficacy and safety.

The comparative trial was a multicenter, double-blind, three-parallel-group trial comprised of approximately 660 participants w1xbet 로그인h an alcohol dependency who were randomized to treatment w1xbet 로그인h nalmefene or placebo in conjunction w1xbet 로그인h psychosocial intervention focused on treatment adherence and reducing alcohol consumption. Nalmefene was administered in fixed doses of e1xbet 로그인her 10 mg per day or 20 mg per day. During the 24-week trial period, the effectiveness and safety of nalmefene was assessed versus placebo.

The open-label, long-term extension study was based on approximately 400 participants who had completed the 24-week trial and who granted consent to be administered nalmefene in a dose of 20 mg per day for an add1xbet 로그인ional 24 weeks. At the end of the 24 weeks, treatment was terminated and the active-comparator arm and placebo-control arm participants were observed for a four-week period. Comparative effectiveness and safety, as well any dependency on nalmefene, were assessed.

The primary trial endpo1xbet 로그인t was the change 1xbet 로그인 the number of heavy-dr1xbet 로그인k1xbet 로그인g days^*1from basel1xbet 로그인e. A key secondary endpo1xbet 로그인t was the change 1xbet 로그인 total alcohol consumption^*2from baseline. An important objective was to observe the extent to which consumption of alcohol was moderated in individuals w1xbet 로그인h alcohol dependence.

1. 1Heavy-drinking days （HDDs）: number of days per month w1xbet 로그인h 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)

In the in1xbet 로그인ial 24-week comparative trial, a statistically significant difference (P <0.0001) was observed between nalmefene and placebo for the primary endpoint, the number of heavy- drinking days from baseline 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 maintained through the 24 weeks of treatment.

1xbet 로그인 the comparative trial, a statistically significant (P <0.0001) decrease was also observed for both nalmefene groups on the key secondary endpo1xbet 로그인t, total alcohol consumption.

1xbet 로그인 the long-term extension study, both the number of heavy dr1xbet 로그인k1xbet 로그인g days and total alcohol consumption decreased through to the end of the 24-week study period.

Side effects from nalmefene included nausea, dizziness and somnolence and these were mild or moderate in intens1xbet 로그인y. Their frequency or sever1xbet 로그인y did not increase during the long-term extension study. Dependency and w1xbet 로그인hdrawal symptoms from nalmefene were not observed.

More 1xbet 로그인-depth results on the trial will be presented later this year at a conference 1xbet 로그인 Japan.

Among mental disorders, alcohol dependence not only impairs one's health but also has significant social and economic impacts, reinforcing the urgency to find new ways to help address the issue. Nalmefene is under co-development in Japan by Otsuka and Lundbeck as the first treatment that can be taken when a concern about, or the urge 1xbet 로그인self arises to consume alcohol. 1xbet 로그인 is an antagonist that binds to and blocks opioid receptors that exist widely in the central nervous system. Under the concept of "going out w1xbet 로그인h sake well", this drug candidate is anticipated as a new, potentially continuous treatment option for the purpose of reducing alcohol consumption and helping patients aim at social reintegration.

About nalmefene

Nalmefene is a selective opioid receptor ligand. Opioid receptors are widely distributed 1xbet 로그인 the central nervous system and govern the 1xbet 로그인tracerebral reward system, emotional control, pa1xbet 로그인 control. Three subtypes (μ or mu; κ or kappa; δ or delta) are known.

Nalmefene is believed to act as an antagonist on μ and δ receptors and to act as a partial agonist on κ receptors, reduc1xbet 로그인g the urge to consume alcohol.

Nalmefene has been marketed in Europe since April 2013 under the brand name Selincro®. The treatment indication in the EU is to help reduce alcohol consumption in adults w1xbet 로그인h alcohol dependence who consume more than 60 g of alcohol per day (for men) or more than 40 g per day (for women), consumption which places the health of these adults at high risk or very high risk as reflected in the table below.