Otsuka’s Simtriyo Secures FDA Nod as First‑in‑Class ADHD Therapy
The FDA approved Otsuka’s once-daily Simtriyo (centanafadine) for ADHD in patients 6 years and older, marking a first‑in‑class norepinephrine, dopamine, serotonin reuptake inhibitor. A potential DEA scheduling decision could affect uptake, but four phase 3 trials showed symptom improvement with a large, under‑penetrated market and potential peak sales around $610 million; the drug originated from Otsuka’s 2017 Neurovance acquisition.