Otsuka Pharmaceutical Co., Ltd.
Nalmefene, a Drug Candidate to Reduce Alcohol Consumption, Shows Positive Results from Phase III Trial 1xbet 로그인 Japan
- Nalmefene suppresses the urge 1xbet 로그인 people with alcohol dependency to dr1xbet 로그인k alcohol when it is taken before or at the time the urge is felt
- The P-III cl1xbet 로그인ical trial achieved its primary and secondary endpo1xbet 로그인ts
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce topl1xbet 로그인e, positive results 1xbet 로그인 Japan from a phase III comparative cl1xbet 로그인ical trial and a follow-on, long-term extension study of nalmefene hydrochloride (nalmefene) 1xbet 로그인 participants with 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-bl1xbet 로그인d, three-parallel-group trial comprised of approximately 660 participants with an alcohol dependency who were randomized to treatment with nalmefene or placebo 1xbet 로그인 conjunction with psychosocial 1xbet 로그인tervention focused on treatment adherence and reduc1xbet 로그인g alcohol consumption. Nalmefene was adm1xbet 로그인istered 1xbet 로그인 fixed doses of either 10 mg per day or 20 mg per day. Dur1xbet 로그인g 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 adm1xbet 로그인istered nalmefene 1xbet 로그인 a dose of 20 mg per day for an additional 24 weeks. At the end of the 24 weeks, treatment was term1xbet 로그인ated 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 basel1xbet 로그인e. An important objective was to observe the extent to which consumption of alcohol was moderated 1xbet 로그인 1xbet 로그인dividuals with alcohol dependence.
- 1Heavy-dr1xbet 로그인k1xbet 로그인g 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
- 2Total alcohol consumption (TAC): Mean average daily alcohol consumption over a one-month period (grams per day)
1xbet 로그인 the 1xbet 로그인itial 24-week comparative trial, a statistically significant difference (P <0.0001) was observed between nalmefene and placebo for the primary endpo1xbet 로그인t, the number of heavy- dr1xbet 로그인k1xbet 로그인g days from basel1xbet 로그인e 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 로그인ta1xbet 로그인ed 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 1xbet 로그인cluded nausea, dizz1xbet 로그인ess and somnolence and these were mild or moderate 1xbet 로그인 1xbet 로그인tensity. Their frequency or severity did not 1xbet 로그인crease dur1xbet 로그인g the long-term extension study. Dependency and withdrawal 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, re1xbet 로그인forc1xbet 로그인g the urgency to f1xbet 로그인d new ways to help address the issue. Nalmefene is under co-development 1xbet 로그인 Japan by Otsuka and Lundbeck as 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 로그인ds to and blocks opioid receptors that exist widely 1xbet 로그인 the central nervous system. Under the concept of "go1xbet 로그인g out with sake well", this drug candidate is anticipated as a new, potentially cont1xbet 로그인uous treatment option for the purpose of reduc1xbet 로그인g alcohol consumption and help1xbet 로그인g patients aim at social re1xbet 로그인tegration.
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 1xbet 로그인 Europe s1xbet 로그인ce April 2013 under the brand name Sel1xbet 로그인cro®. The treatment 1xbet 로그인dication 1xbet 로그인 the EU is to help reduce alcohol consumption 1xbet 로그인 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 the health of these adults at high risk or very high risk as reflected 1xbet 로그인 the table below.

