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Centanafadine Receives FDA Approval for the Treatment of ADHD
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ADDitude
Over six weeks, adolescent participants received either high-dose centanafadine (328.8 mg), low-dose centanafadine (164.4 mg), or placebo; children were similarly assigned to a high-dose, low-dose, or placebo group, with doses based on their weight.
About half of the adolescents who received high-dose centanafadine and a third of children in the high-dose centanafadine group demonstrated an 18-point or greater reduction on the ADHD-RS-5 compared with 23% in the placebo group.
)2, 3Adults with ADHD also demonstrated statistically significant improvements, according to two randomized trials evaluating sustained-release (SR) centanafadine.
A double-blind, placebo-controlled Phase 3 trial involving 859 adults with ADHD between the ages of 18 and 55 randomly assigned participants to high-dose centanafadine (400 mg), low-dose centanafadine (200 mg), or placebo twice daily for six weeks.
According to the study, AISRS total scores increased up to 57% in adults who used 400 mg centanafadine SR twice daily.