The U.S. FDA has approved Simtriyo (centranafadine), a once-daily, extended-release capsule from Otsuka Pharmaceutical Co. to treat attention-deficit hyperactivity disorder (ADHD).
Simtriyo is the first norepinephrine, dopamine and serotonin reuptake inhibitor (NDSRI) to treat ADHD. This new approach to treatment increases the availability of the neurotransmitters for pathways involved in attention and behavioral regulation. The drug will hit the market later this year after scheduling by the DEA.
Approval is based on four phase 3 trials that showed statistically-significant and clinically-meaningful improvements in ADHD symptoms compared to a placebo using the ADHD Rating Scale-5. Improvements in symptoms began as early as week 1. The drug also had a well-characterized safety profile.