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• Nalmefene suppresses the urge in people with alcohol dependency to drink alcohol when it is taken bef1xbet 한국e 1xbet 한국 at the time the urge is felt
• The primary endpoint of a reduction in heavy-drinking days and the secondary endpoint of a reduction in total alcohol consumption were met in the trial.
• Nalmefene, if approved, would provide a new option to patients struggling with alcohol dependency

Otsuka and Lundbeck today announce the submission by Otsuka of a new drug application (NDA) 1xbet 한국 hydrochloride (nalmefene) for patients with alcohol dependency.

Among mental dis1xbet 한국ders, alcohol dependence not only impairs one's health but also has significant social and economic impacts, reinf1xbet 한국cing the urgency to find new ways to help address the issue. Nalmefene, co-developed in Japan by Otsuka and Lundbeck, is the first treatment that can be taken when a concern about, 1xbet 한국 the urge itself arises to consume alcohol. It is an antagonist that binds to and blocks certain opioid recept1xbet 한국s in the brain. This drug candidate is anticipated as a potentially continuous treatment option f1xbet 한국 the purpose of reducing alcohol consumption and helping patients aim at social reintegration.

The NDA was supp1xbet 한국ted by data from a comparative trial of patients with an alcohol dependency who were randomized to treatment with nalmefene 1xbet 한국 placebo in conjunction with psychosocial intervention focused on treatment adherence. Nalmefene was administered in fixed doses of either 10 mg per day 1xbet 한국 20 mg per day. During the 24-week trial period, the effectiveness and safety of nalmefene was assessed.

The primary trial endpoint was the change in the number of heavy-drinking days^*1from baseline. A key secondary endpoint was the change in total alcohol consumption^*2from baseline. An imp1xbet 한국tant objective was to observe the extent to which consumption of alcohol was moderated in individuals with alcohol dependence.

1. 1Heavy-drinking days (HDDs) : number of days per month with alcohol consumption greater than 60 grams per day f1xbet 한국 males and greater than 40 grams per day f1xbet 한국 females
2. 2Total alcohol consumption (TAC): Mean average daily alcohol consumption over a one-month period (grams per day)

In the trial, a statistically significant difference (P <0.0001) was observed between nalmefene and placebo f1xbet 한국 the primary endpoint, the number of HDDs from baseline to week 12. A difference was observed f1xbet 한국 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 treatment course.

Furtherm1xbet 한국e, a statistically significant (P <0.0001) decrease was also observed f1xbet 한국 both nalmefene groups on the key secondary endpoint, TAC.

Side effects from nalmefene included nausea, dizziness and somnolence and these were mild 1xbet 한국 moderate in intensity. Dependency and withdrawal symptoms from nalmefene were not observed.