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Otsuka preps for July decision on centanafadine for ADHD
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pharmaphorum
The FDA has started a priority review of Otsuka Pharma's triple-acting drug for attention-deficit hyperactivity disorder (ADHD), centanafadine, setting up a decision by 24th July.
The marketing application is backed by four phase 3 trials, which showed that centanafadine achieved statistically significant improvements in ADHD symptoms, based on the ADHD-RS-5 scale in children and adolescents and the AISRS scale in adults.
Other recent launches include Noven's stimulant therapy Xelstrym (dextroamphetamine), the first transdermal patch-based therapy for ADHD, which was launched in 2022.
ADHD affects approximately 7 million children in the US and an estimated 15.5 million adults, according to figures from the Centers for Disease Control and Prevention (CDC).
"ADHD manifests differently across patients, highlighting the importance of having multiple therapeutic approaches available," said John Kraus, Otsuka Pharma's chief medical officer.