Otsuka Pharmaceutical plans to launch Simtriyo—the first norepinephrine, dopamine, serotonin reuptake inhibitor—later this year following scheduling by the U.S. Drug Enforcement Agency.
The FDA has greenlit Otsuka Pharmaceutical’s daily pill centanafadine for patients with attention-deficit hyperactivity disorder, opening up a new treatment class for the indication.
With its approval, Simtriyo is the first norepinephrine, dopamine, serotonin reuptake inhibitor on the U.S. market, Otsuka said in a news release on Friday. The drug is indicated for patients aged 6 years and older who weigh at least 20 kg.
The FDA slapped a boxed warning on Simtriyo, flagging a risk of suicidal ideation and behaviors, as well as of abuse, misuse and addiction. Controlled substance scheduling is pending for the drug, according to its label. Otsuka said it expects to make Simtriyo available “later this year” after scheduling by the U.S. Drug Enforcement Agency.
Jefferies analysts were bullish about the approval, calling it an “important de-risking event,” in a note to investors on Sunday. The FDA’s verdict “marks the arrival of Otsuka’s next major CNS launch,” the firm continued, adding that the pharma has previously forecasted peak sales of more than ¥100 billion (around $615 million) for Simtriyo.
“The ADHD market remains large and under-penetrated,” Jefferies said, particularly for non-stimulant agents like Simtriyo. “We believe Simtriyo is well positioned to address patients seeking alternatives to traditional stimulant therapies.”
The group also appeared unbothered by Simtriyo’s pending designation as a controlled substance, instead viewing it as a potential opportunity for Otsuka to carve out an advantage in the market.
“As with all newly approved ADHD therapies, Simtriyo must now undergo DEA review,” the analysts wrote. While being unscheduled is likely “the most favorable regulatory outcome” for the drug, even less restrictive scheduling “could prove commercially advantageous,” Jefferies noted, explaining that such schedules could position Simtriyo between traditional stimulants—which are typically given more stringent DEA schedules—and non-stimulants, “potentially enhancing its differentiation.”
The FDA’s nod was supported by data from four Phase 3 trials. Two of these studies, which focused on adult patients, showed that the drug significantly improved ADHD symptoms versus placebo, according to Otsuka’s news release on Friday. These benefits occurred as early as week 1 and were sustained throughout six weeks of treatment.
The two other trials focused on pediatric and adolescent patients, and likewise showed significant symptomatic improvement.
