IPM Take
ADHD does not politely disappear when anxiety arrives.
Yet treatment evidence has often been built around the conveniently uncomplicated patient: one diagnosis, one symptom set, one clean trial population. Otsuka’s new centanafadine study does not make the medicine approved, and it does not solve the clinical reality of ADHD with anxiety. But it does something that should not be unusual: it studies the people clinicians actually see.
That is not a side point. It is the point.
Executive Summary
Otsuka reported positive topline results from a randomised, double-blind, placebo-controlled Phase 3b study of centanafadine XR 280 mg once daily in 315 adults aged 18–65 with ADHD and comorbid generalised anxiety disorder and/or social anxiety disorder.
At eight weeks, Otsuka reported a greater reduction in ADHD symptoms on the Adult Investigator Symptom Rating Scale with centanafadine than placebo: −18.5 versus −12.6 points; treatment difference −5.87; p<0.0001. The company also reported a statistically significant difference on the Hamilton Anxiety Rating Scale: −12.5 versus −10.6 points; treatment difference −1.92; p=0.02. These are company-reported topline results and have not yet been published in a peer-reviewed journal.
Centanafadine remains investigational. It is under FDA Priority Review for ADHD in children, adolescents and adults, with a target action date of 24 July 2026. The study does not create a separate regulatory indication for ADHD with anxiety. (otsuka-us.com)
Why it matters
- Patients / advocates: ADHD and anxiety often arrive together. Evidence should reflect that reality instead of forcing people into artificial diagnostic boxes.
- Clinicians: The signal is encouraging, but eight weeks of topline data cannot answer the harder questions around long-term safety, durability, function or the role of a new medicine alongside psychotherapy and existing treatments.
- Regulators: Common comorbidity should not automatically be treated as a reason to exclude people from trials. It is often the reason treatment becomes more difficult.
ADHD and anxiety are often managed as though they take turns.
One diagnosis is treated first. The other is monitored, deferred or folded into the side-effect conversation. Patients live with the messier version: poor concentration can fuel anxiety, anxiety can make attention worse, and treatment becomes a balancing act rather than a clean pathway.
Otsuka’s Phase 3b study is notable because it did not remove that complexity from the room. It enrolled adults with ADHD alongside generalised anxiety disorder and/or social anxiety disorder, then reported statistically significant improvements in both ADHD symptom scores and anxiety measures after eight weeks.
The findings need restraint. This is a company announcement, not a peer-reviewed publication. The reported improvement in anxiety was modest. The study does not tell us whether people stay in work more easily, reduce reliance on other medicines, sustain relationships better or experience meaningful benefit over years rather than weeks.
But trial design still matters.
Evidence decides who appears in the data, whose symptoms are treated as central, and whose experience is left for a clinician to solve after the trial is over. For adults living with ADHD and anxiety, the question is not whether one diagnosis is more legitimate than the other.
It is whether the system is finally willing to study the patient as a whole person.
