In four pivotal Phase 3 clinical trials evaluating the efficacy and safety of centanafadine across pediatric and adult patient populations, centanafadine demonstrated statistically significant efficacy for the core symptoms of inattention and hyperactivity-impulsivity in ADHD.
Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announce the filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for centanafadine, once daily extended release capsules, a novel norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI), for the treatment of attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults. The NDA submission is supported by results from four pivotal Phase 3 clinical trials evaluating the efficacy and safety of centanafadine across patient populations.
Health Technology Insights: CharmHealth Reimagines Medical Billing With New CharmBillerPro Platform
“As an innovator in mental health, we are pleased to take this important step forward in the hope of providing a novel treatment option to patients living with ADHD,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. “Centanafadine represents a first in class mechanism of action among available ADHD therapies, and if approved, may expand the range of options available to those managing this complex condition. We are grateful to the patients and caregivers for their participation in these trials.”
Health Technology Insights: Shore Capital Merges Reliant Healthcare and Care Fusion Rx
In Phase 3 clinical studies with children, adolescents, and adults, centanafadine demonstrated statistically significant and clinically meaningful improvements in ADHD symptoms compared with placebo, as measured by the ADHD Rating Scale – 5 (ADHD-RS-5) in adolescents and children, and the ADHD Investigator Symptom Rating Scale (AISRS) in adults. Centanafadine was generally well tolerated across studies, with the most common adverse events including decreased appetite, nausea, rash, fatigue, abdominal pain, and somnolence in children and adolescents, and decreased appetite and headache in adults.
About the Phase 3 Clinical Trial Program
The Phase 3 program for centanafadine provides a robust clinical evaluation of the first investigational NDSRI ADHD therapy. The clinical program consists of four different pivotal Phase 3 trials that evaluated the efficacy and safety of centanafadine across children, adolescents, and adult..
The pivotal Phase 3 trial in children (NCT05428033) was a randomized, double-blind, three-arm, fixed-dose study evaluating the efficacy, safety, and tolerability of centanafadine in children aged 4 to 12 years with ADHD. Participants received a weight-based high dose, low dose, or placebo for 6 weeks. The primary endpoint was the change from baseline in ADHD-RS-5 total score at Week 6. The high-dose group demonstrated statistically significant improvement versus placebo, while the low-dose group did not reach statistical significance. Centanafadine showed a favorable safety and tolerability profile and a low potential for abuse and dependence, with the most frequently reported adverse events including decreased appetite, rash, and vomiting.
The pivotal Phase 3 trial in adolescents (NCT05257265) was a randomized, double-blind, three-arm, fixed-dose study designed to evaluate the efficacy, safety, and tolerability of centanafadine in adolescents aged 13 to 17 years with ADHD. Participants received either a high dose, low dose, or placebo over a 6-week treatment period. The primary endpoint was change from baseline in the ADHD Rating Scale-5 (ADHD-RS-5) total score at Week 6. The high-dose group achieved statistically significant and clinically meaningful reductions in ADHD symptoms compared with placebo. Centanafadine showed a favorable safety and tolerability profile and a low potential for abuse and dependence, with the most common adverse events including decreased appetite, nausea, headache, and rash.
The two pivotal Phase 3 trials in adults (NCT03605680, NCT03605836) were randomized, double-blind, placebo-controlled studies designed to evaluate the efficacy, safety, and tolerability of centanafadine sustained-release (SR) tablet in adults aged 18 to 55 years with ADHD. Participants received either centanafadine 200 mg/day, 400 mg/day, or placebo over a 6-week treatment period. The primary endpoint was the change from baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score at Week 6. Both centanafadine dose groups demonstrated statistically significant and clinically meaningful improvements versus placebo. In both studies, centanafadine showed a favorable safety and tolerability profile and a low potential for abuse and dependence, with the most common adverse events including decreased appetite and headache.
About Attention-Deficit Hyperactivity Disorder (ADHD)
ADHD is a chronic neurodevelopmental disorder characterized primarily by impairments in attention, hyperactivity, and impulsivity. It affects approximately 7 million children in the U.S. and an estimated 15.5 million adults, according to the Centers for Disease Control and Prevention.
Health Technology Insights: NRC Health Appoints David Burik as Executive Vice President, Strategic Insights
To participate in our interviews, please write to our HealthTech Media Room at info@intentamplify.com
Source- businesswire
