New ADHD drug! Otsuka triple reuptake inhibitor centanafadine 2 adult Phase III clinical success!
Last Update: 2020-06-16
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JUNE 12, 2020 /PRNewswire/ -- Japanese pharmaceutical company Otsuka Pharma and its U.Ssubsidiary Otsuka Pharmaceutical Development and CommercialIzation Co., Dayu Pharmaceuticals have jointly announced positive results from two six-week Phase III clinical trials for the treatment of adhile hyperactivity disorder (ADHD), or ADHD, in adult patients with oral centancentafadinecentanafadine is a combination of 5-serotonin, norepinephrine, dopamine triple reuptake inhibitors and is currently being developed to treat ADHD in adultsOtsuka also plans to investigate the drug's treatment of children with ADHD and discuss the next steps with the U.SFood and Drug Administration (FDA)In the two Phase III studies, about 900 adult patients between the ages of 18 and 55 who were diagnosed with ADHD were randomly divided into two groupsThese studies were randomized, double-blind, multicenter, placebo-controlled, parallel group studiesPatients were randomly assigned at a ratio of 1:1 to 1:1, received a dose of 100 mg or 200 mg of centanafadine, twice daily (total daily dose scored 200 mg or 400 mg), or received a placebo twice a dayAt present, Otsuka is conducting a long-term safety and tolerance study of centanafadine with a total daily dose of 400 mg, and the latest results are expected by 2021In these two Phase III studies, centanafadine (pictured: Wikipedia) showed a statistically significant improvement in both the primary and key secondary efficacy endpoints of centanafadine, which were given one dose of 200 mg and 400 mg daily compared to placebosKey efficacy endpoint data showed a statistically significant improvement in the 2 studies compared to placebos, 200 mg and 400 mg dosecentcents centanafadine in adult ADHD researchers' total symptom assessment scale (AISRS) from baseline to 42 days (p 0.05 in the first study, p 0.01 in the second study)AISRS is an interview-based measure of ADHD symptoms in adult patients, including hyperactivity/impulsiveness and inattentionKey secondary efficacy endpoint data show edified: In two studies, centanafadine also showed a statistically significant improvement in changes in the overall clinical impression-severity scale (CGI-S) from baseline to 42 days compared to placebos (p 0.05)In a summary analysis of 2 studies, the most common side effects observed in centanafadine (incidence of approximately 5% and more frequent than placebo) included decreased appetite, headache, nausea, dry mouth, upper respiratory tract infections and diarrhea; According to the Attention Deficit Disorder Association (ADDA), about 5 percent (11 million) of adults in the United States have ADHD, a neurological behavior disorder that affects specific brain functions and related behavioral regulationsThese brain functions include important functions such as attention, attention, memory, motivation and effort, learning from mistakes, impulsivity, ADHD, organizational and social skillsThere is no known cure for ADHD, and most people cannot get rid of the diseaseAbout two-thirds or more of children with ADHD still have symptoms and disease challenges as adults (BioValley Bioon.com) Original source: By-The-Two Phase 3 Phase 3 Studies of Centanafadine for The Treatment-Deficit Hyperactivity Disorder (ADHD) in Adult Patients
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