Otsuka Pharmaceutical Co. Ltd. reported another clinical study win with once-daily centanafadine, a non-stimulant compound targeting attention deficit hyperactivity disorder (ADHD). Top-line results of a dedicated phase IIIb study in patients with ADHD and comorbid anxiety found that centanafadine met the primary endpoint, defined as score improvements on the Adult Investigator Symptom Rating Scale, compared with placebo at week 8.

Otsuka Pharmaceutical Co. Ltd. reported another clinical study win with once-daily centanafadine, a non-stimulant compound targeting attention deficit hyperactivity disorder (ADHD). Top-line results of a dedicated phase IIIb study in patients with ADHD and comorbid anxiety found that centanafadine met the primary endpoint, defined as score improvements on the Adult Investigator Symptom Rating Scale, compared with placebo at week 8.

The eighth version of the Prescription Drug User Fee Act (PDUFA) is up for renewal next year, but the bulk of the negotiations between the drug development industry and the U.S. FDA is largely complete. At the BIO International Convention, representatives from the industry and trade organization provided an overview of what was agreed upon during the 127 negotiating sessions that were needed to arrive at the commitment letter, which will be sent to Congress later in 2026.