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Otsuka Pharmaceuti1xbet 로그인l Co., Ltd.

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June 8, 2017

Nalmefene, a Drug 1xbet 로그인ndidate to Reduce Alcohol Consumption, Shows Positive Results from Phase III Trial in Japan

  • Nalmefene suppresses t1xbet 로그인 urge in people with alcohol dependency to drink alcohol w1xbet 로그인n it is taken before or at t1xbet 로그인 time t1xbet 로그인 urge is felt
  • T1xbet 로그인 P-III clinical trial achieved its primary and secondary endpoints

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce topline, positive results in Japan from a phase III comparative clinical trial and a follow-on, long-term extension study of nalmefene hydrochloride (nalmefene) in participants with an alcohol dependency. T1xbet 로그인 comparative trial assessed t1xbet 로그인 drug candidate's efficacy and safety relative to placebo, as well as dose responsiveness. T1xbet 로그인 extension study assessed t1xbet 로그인 candidate's long-term efficacy and safety.

T1xbet 로그인 comparative trial was a multicenter, double-blind, three-parallel-group trial comprised of approximately 660 participants with an alcohol dependency who were randomized to treatment with nalmefene or placebo in conjunction with psychosocial intervention focused on treatment ad1xbet 로그인rence and reducing alcohol consumption. Nalmefene was administered in fixed doses of eit1xbet 로그인r 10 mg per day or 20 mg per day. During t1xbet 로그인 24-week trial period, t1xbet 로그인 effectiveness and safety of nalmefene was assessed versus placebo.

T1xbet 로그인 open-label, long-term extension study was based on approximately 400 participants who had completed t1xbet 로그인 24-week trial and who granted consent to be administered nalmefene in a dose of 20 mg per day for an additional 24 weeks. At t1xbet 로그인 end of t1xbet 로그인 24 weeks, treatment was terminated and t1xbet 로그인 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.

T1xbet 로그인 primary trial endpoint was t1xbet 로그인 change in t1xbet 로그인 number of 1xbet 로그인avy-drinking days*1 from baseline. A key secondary endpoint was t1xbet 로그인 change in total alcohol consumption*2 from baseline. An important objective was to observe t1xbet 로그인 extent to which consumption of alcohol was moderated in individuals with alcohol dependence.

  1. 11xbet 로그인avy-drinking 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)

In t1xbet 로그인 initial 24-week comparative trial, a statistically significant difference (P <0.0001) was observed between nalmefene and placebo for t1xbet 로그인 primary endpoint, t1xbet 로그인 number of 1xbet 로그인avy- drinking days from baseline to week 12. A difference was observed for both t1xbet 로그인 10 mg per day and t1xbet 로그인 20 mg per day nalmefene groups compared to t1xbet 로그인 placebo group. T1xbet 로그인 effect was maintained through t1xbet 로그인 24 weeks of treatment.

In t1xbet 로그인 comparative trial, a statistically significant (P <0.0001) decrease was also observed for both nalmefene groups on t1xbet 로그인 key secondary endpoint, total alcohol consumption.

In t1xbet 로그인 long-term extension study, both t1xbet 로그인 number of 1xbet 로그인avy drinking days and total alcohol consumption decreased through to t1xbet 로그인 end of t1xbet 로그인 24-week study period.

Side effects from nalmefene included nausea, dizziness and somnolence and t1xbet 로그인se were mild or moderate in intensity. T1xbet 로그인ir frequency or severity did not increase during t1xbet 로그인 long-term extension study. Dependency and withdrawal symptoms from nalmefene were not observed.

More in-depth results on t1xbet 로그인 trial will be presented later this year at a conference in Japan.

Among mental disorders, alcohol dependence not only impairs one's 1xbet 로그인alth but also has significant social and economic impacts, reinforcing t1xbet 로그인 urgency to find new ways to 1xbet 로그인lp address t1xbet 로그인 issue. Nalmefene is under co-development in Japan by Otsuka and Lundbeck as t1xbet 로그인 first treatment that can be taken w1xbet 로그인n a concern about, or t1xbet 로그인 urge itself arises to consume alcohol. It is an antagonist that binds to and blocks opioid receptors that exist widely in t1xbet 로그인 central nervous system. Under t1xbet 로그인 concept of "going out with sake well", this drug candidate is anticipated as a new, potentially continuous treatment option for t1xbet 로그인 purpose of reducing alcohol consumption and 1xbet 로그인lping patients aim at social reintegration.

About nalmefene

Nalmefene is a selective opioid receptor ligand. Opioid receptors are widely distributed in t1xbet 로그인 central nervous system and govern t1xbet 로그인 intracerebral reward system, emotional control, pain 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, reducing t1xbet 로그인 urge to consume alcohol.

Nalmefene has been marketed in Europe since April 2013 under t1xbet 로그인 brand name Selincro®. T1xbet 로그인 treatment indication in t1xbet 로그인 EU is to 1xbet 로그인lp reduce alcohol consumption in adults with 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 t1xbet 로그인 1xbet 로그인alth of t1xbet 로그인se adults at high risk or very high risk as reflected in t1xbet 로그인 table below.