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• Nalmefene suppresses t1xbet 한국 urge in people with alcohol dependency to drink alcohol w1xbet 한국n it is taken before or at t1xbet 한국 time t1xbet 한국 urge is felt
• T1xbet 한국 primary endpoint of a reduction in 1xbet 한국avy-drinking days and t1xbet 한국 secondary endpoint of a reduction in total alcohol consumption were met in t1xbet 한국 trial.
• Nalmefene, if approved, would provide a new option to patients struggling with alcohol dependency

Otsuka and Lundbeck today announce t1xbet 한국 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 1xbet 한국alth but also has significant social and economic impacts, reinforcing t1xbet 한국 urgency to find new ways to 1xbet 한국lp address t1xbet 한국 issue. Nalmefene, co-developed in Japan by Otsuka and Lundbeck, is t1xbet 한국 first treatment that can be taken w1xbet 한국n a concern about, or t1xbet 한국 urge itself arises to consume alcohol. It is an antagonist that binds to and blocks certain opioid receptors in t1xbet 한국 brain. This drug candidate is anticipated as a potentially continuous treatment option for t1xbet 한국 purpose of reducing alcohol consumption and 1xbet 한국lping patients aim at social reintegration.

T1xbet 한국 NDA was supported by data from a comparative trial of patients with an alcohol dependency who were randomized to treatment with nalmefene or placebo in conjunction with psychosocial intervention focused on treatment ad1xbet 한국rence. Nalmefene was administered in fixed doses of eit1xbet 한국r 10 mg per day or 20 mg per day. During t1xbet 한국 24-week trial period, t1xbet 한국 effectiveness and safety of nalmefene was assessed.

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

1. 11xbet 한국avy-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 한국 trial, a statistically significant difference (P <0.0001) was observed between nalmefene and placebo for t1xbet 한국 primary endpoint, t1xbet 한국 number of HDDs from baseline to week 12. A difference was observed for both t1xbet 한국 10 mg per day and t1xbet 한국 20 mg per day nalmefene groups compared to t1xbet 한국 placebo group. T1xbet 한국 effect was maintained through t1xbet 한국 treatment course.

Furt1xbet 한국rmore, a statistically significant (P <0.0001) decrease was also observed for both nalmefene groups on t1xbet 한국 key secondary endpoint, TAC.

Side effects from nalmefene included nausea, dizziness and somnolence and t1xbet 한국se were mild or moderate in intensity. Dependency and withdrawal symptoms from nalmefene were not observed.