Otsuka’s Simtriyo Secures FDA Nod as First‑in‑Class ADHD Therapy
TL;DR Summary
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.
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- FDA Approves Centanafadine for ADHD in Children, Adolescents, and Adults Psychiatric Times
- Otsuka’s ADHD approval opens up new drug class with $615M opportunity BioSpace
- Otsuka's triple reuptake inhibitor Simtriyo wins FDA OK for ADHD FirstWord Pharma
- FDA Approves Simtriyo | PharmExec Pharmaceutical Executive
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