Otsuka Reports the US FDA Approval for Simtriyo to Treat ADHD
Shots:
- The US FDA has approved Simtriyo (centanafadine) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pts (≥6yrs.; ≥20kg), with availability expected later this year following scheduling by the US DEA
- Approval was supported by 4 P-III trials assessing Simtriyo vs PBO in children, adolescents, & adults with ADHD
- In two adult studies, both Simtriyo dose groups significantly improved AISRS total scores, with benefits emerging by Wk. 1 & sustained through 6wks. In paediatric & adolescent studies, high-dose Simtriyo significantly improved ADHD-RS-5 scores, with improvements seen as early as Wk. 1
Ref: Otsuka | Image: Otsuka | Press Release
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