Otsuka receives FDA approval for Simtriyo, first norepinephrine-dopamine-serotonin reuptake inhibitor for ADHD

Otsuka Pharmaceutical announced that the FDA has approved its daily pill centanafadine, branded as Simtriyo, for the treatment of attention-deficit hyperactivity disorder in patients six years and older who weigh at least 20 kg.

Simtriyo is the first drug in the United States to combine norepinephrine, dopamine and serotonin reuptake inhibition, creating a new therapeutic class for ADHD.

The approval includes a boxed warning about suicidal thoughts and a potential for abuse, and the drug is awaiting controlled-substance scheduling by the U.S. Drug Enforcement Agency.

Analysts at Jefferies called the decision a major de-risking event and noted Otsuka’s forecast of peak sales exceeding ¥100 billion (about $615 million).