What Happened?

If you have ADHD and your doctor prescribes Simtriyo, the pharmacy filling it must now meet the same federal security, recordkeeping, and prescription rules that apply to other controlled substances. The Drug Enforcement Administration (DEA) placed centanafadine, sold as Simtriyo, in Schedule III of the Controlled Substances Act, effective Oct. 30, according to a Legis1 review of the Federal Register rule. ​

The Food and Drug Administration (FDA) approved Simtriyo on July 24 for treating attention-deficit/hyperactivity disorder (ADHD) in adults and children ages 6 and older who weigh at least 20 kilograms, roughly 44 pounds. Everyone who handles the drug commercially, including manufacturers, distributors, pharmacies, and prescribers, must now register with the DEA and meet its security, inventory, and recordkeeping rules.

Why Does it Matter to Me?

Simtriyo can now be legally prescribed and dispensed, but only through the controlled-substance system, meaning your doctor must follow DEA prescription rules and your pharmacy must store it under Schedule III security standards.

The DEA's own eight-factor review concluded that centanafadine meets the Schedule III criteria. The review found its abuse potential is lower than that of substances in Schedules I and II, that it has currently accepted medical use in the United States, and that abuse may lead to moderate or low physical dependence or high psychological dependence. Patients who hold a valid prescription are not subject to the registration or security requirements that apply to businesses.

Both Sides, Now

The DEA used an expedited path that let its interim final rule take effect immediately, without prior notice and comment, under a 2015 law meant to speed scheduling of newly approved drugs so they can be marketed without undue delay after FDA approval. Congress authorized that process through the Improving Regulatory Transparency for New Medical Therapies Act, a 2015 law that lets the DEA skip the usual advance public comment period to avoid delaying newly FDA-approved drugs; the DEA acted under that authority without a separate congressional vote on this specific drug.

The interim rule was not preceded by a public comment period, and the Federal Register notice lists one submission on the rulemaking. Interested parties may submit comments or request a hearing on whether centanafadine meets the Schedule III criteria.

What Happens Next?

Comments and hearing requests are both due Nov. 30, with electronic submissions required by 11:59 p.m. After the comment and hearing process, due by Nov. 30, the DEA must issue a final rule on centanafadine.

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