52-Week Open-Label Safety and Tolerability Study of Centanafadine Sustained Release in Adults With...

Area of Science:

• Neuroscience
• Psychiatry
• Pharmacology

Background:

• Centanafadine (CTN) is a novel norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI).
• CTN is under development for adult attention-deficit/hyperactivity disorder (ADHD) treatment.
• This study assessed the long-term safety, tolerability, and efficacy of CTN sustained release (SR).

Purpose of the Study:

• To evaluate the safety and tolerability of CTN SR in adults with ADHD over 52 weeks.
• To explore the efficacy of CTN SR in treating adult ADHD symptoms.
• To assess the long-term treatment profile of CTN SR.

Main Methods:

• Adult participants received CTN SR 400 mg daily for 52 weeks in an open-label study.
• Safety assessments included adverse events, labs, vital signs, ECGs, and suicidality ratings.
• Exploratory efficacy was measured using the Adult Investigator Symptom Rating Scale (AISRS) and CGI-S.

Main Results:

• 662 adults were enrolled; 345 completed the 52-week trial.
• Most common treatment-emergent adverse events (TEAEs) were insomnia, nausea, diarrhea, and headache, mostly mild/moderate.
• Significant improvements were observed in AISRS total scores (up to 57%) and CGI-S (-1.5 points).

Conclusions:

• CTN SR 400 mg is safe and well-tolerated for long-term ADHD treatment in adults.
• The drug demonstrated significant efficacy in reducing ADHD symptom severity.
• Results support CTN SR as a potential long-term therapeutic option for adult ADHD.