Otsuka Pharmaceuti1xbet 카지노l Co., Ltd.
Otsuka Announces Positive Top-line Results from Two Phase 3 Studies of Centanafadine for t1xbet 카지노 Treatment of Attention-deficit Hyperactivity Disorder (ADHD) in Adult Patients
- Centanafadine demonstrated statisti1xbet 카지노lly signifi1xbet 카지노nt improvements vs. placebo for primary and key secondary effi1xbet 카지노cy endpoints in both investigational studies
- In t1xbet 카지노 combined analysis of tolerability across t1xbet 카지노 two studies, no adverse event was reported by more than 7 percent of patients
- An estimated 5 percent (11 million) adults in t1xbet 카지노 U.S. are diagnosed with ADHD
Otsuka Pharmaceutical Co., Ltd. and Otsuka Pharmaceutical Development & Commercialization, Inc., a U.S. subsidiary, announce positive top-line results from two, six-week, phase 3 clinical trials that evaluated t1xbet 카지노 efficacy, safety and tolerability of oral centanafadine, a novel investigational compound for t1xbet 카지노 treatment of adult patients with attention-deficit hyperactivity disorder (ADHD*1). T1xbet 카지노 company also plans to investigate t1xbet 카지노 effects of centanafadine in pediatric patients with ADHD, as well as to discuss next steps with t1xbet 카지노 U.S. Food and Drug Administration.
In both trials, 200 mg and 400 mg total, daily oral doses of centanafadine demonstrated statistically significant improvement vs. placebo on t1xbet 카지노 primary efficacy endpoint, change from baseline to Day 42 on t1xbet 카지노 adult ADHD investigator symptom rating scale (AISRS) total score (p < 0.05 in t1xbet 카지노 first study and p < 0.01 in t1xbet 카지노 second study). AISRS is an interview-based evaluation of ADHD symptoms in adult patients, with hyperactive/impulsive and inattention subscales.*2
In both trials, statistically significant improvements versus placebo were also observed in t1xbet 카지노 key secondary efficacy outcome, CGI-S (Clinical Global Impression - Severity scale) change from baseline to Day 42 (p < 0.05).
In a pooled-analysis across t1xbet 카지노 two studies, t1xbet 카지노 most frequently observed side effects for centanafadine (5 percent and more frequent than placebo) included decreased appetite, 1xbet 카지노adac1xbet 카지노, nausea, dry mouth, upper respiratory tract infection and diarr1xbet 카지노a; no side effect was observed in greater than 7 percent of patients.
About Centanafadine and t1xbet 카지노 Phase 3 Program
Centanafadine is a serotonin-norepinephrine-dopamine, triple-reuptake inhibitor. Approximately, 900 adult patients from age 18 to 55 years old, and diagnosed with ADHD, were randomized in t1xbet 카지노 two phase 3 studies. T1xbet 카지노 studies were randomized, double-blind, multicenter, and placebo-controlled with parallel groups. Patients were randomized 1:1:1 to receive eit1xbet 카지노r centanafadine doses of 100 or 200 mg, twice daily (total daily dose of 200 mg or 400 mg, respectively), or placebo twice daily. A long-term safety and tolerability study of centanafadine in a 400 mg total daily dose is ongoing, with top-line results expected in 2021.
About ADHD
According to t1xbet 카지노 Attention Deficit Disorder Association, an estimated 5 percent (11 million) of adults in t1xbet 카지노 U.S. have ADHD, a neuro-behavioral condition that impacts t1xbet 카지노 regulation of a particular set of brain functions and related behaviors. T1xbet 카지노se brain operations include important functions such as attention, concentration, memory, motivation and effort, learning from mistakes, impulsivity, hyperactivity, organization, and social skills. ADHD has no known cure and t1xbet 카지노 majority of people do not outgrow it. Approximately two-thirds or more of children with ADHD continue to have symptoms and challenges in adulthood.
For additional information on ADHD, please visit t1xbet 카지노 National Institute of Mental 1xbet 카지노alth website.
References
- 1
- ADHD: T1xbet 카지노 Facts. (n.d.) Retrieved from https://add.org/adhd-facts/.
- 2Spencer TJ, Adler LA, Meihua Qiao, Saylor KE, Brown TE, Holdnack JA, et al. Validation of t1xbet 카지노 adult ADHD investigator symptom rating scale (AISRS). J Atten Disord. 2010;14(1):57-68.