Definium Therapeutics reports real-world GAD data showing frequent treatment discontinuation, switching, and long care gaps, highlighting unmet treatment needs.
Written By: Fariha Sameen, PharmD
Reviewed By: Pharmacally Editorial Team
Generalized anxiety disorder (GAD) remains difficult to manage with currently available medications, according to a large real-world analysis from Definium Therapeutics. Published in CNS Spectrums, the healthcare claims study found that many patients discontinued treatment early, frequently switched therapies, or experienced prolonged gaps in care, despite clinical recommendations to continue treatment for at least six to 12 months to reduce the risk of relapse.
The retrospective study evaluated treatment patterns in more than 1.27 million U.S. adults with GAD using the Komodo Healthcare Map™, a longitudinal medical and pharmacy claims database. The findings provide one of the largest real-world assessments of pharmacotherapy use among both newly diagnosed and established GAD patients.
Early treatment discontinuation remains common
The analysis included 259,158 newly diagnosed patients and 1,018,288 patients with established GAD who received pharmacotherapy between January 2020 and December 2024.
Among newly diagnosed patients, 55% discontinued their initial treatment, while 28% either switched medications or added another therapy. In patients with established GAD, 16% discontinued treatment and 55% modified therapy through switching or combination treatment.
Treatment changes occurred rapidly. Newly diagnosed patients switched medications after a median of 31 days and initiated combination therapy after 49 days. Established patients switched after a median of 42 days and added combination therapy after 32 days.
Patients also discontinued treatment much earlier than recommended. Median time to discontinuation was 84 days for newly diagnosed patients and 119 days for those with established disease.
More than half (57%) of newly diagnosed patients who stopped treatment never restarted therapy during the study period. Among those who resumed treatment, the median interruption lasted 146 days for newly diagnosed patients and 96 days for established patients.
The study also showed that treatment instability often persisted. Within 12 months, 75% of newly diagnosed patients and 94% of established patients who had already modified therapy experienced at least one additional treatment change.
Findings highlight unmet need in GAD treatment
GAD affects an estimated 26 million adults in the United States and is characterized by persistent, excessive worry that interferes with daily functioning. Although several pharmacological treatments are available, many patients fail to achieve sustained symptom control or discontinue therapy because of inadequate efficacy or adverse effects, including weight gain and sexual dysfunction.
According to study co-author Roger S. McIntyre, MD, Professor of Psychiatry and Pharmacology at the University of Toronto, the findings demonstrate that many patients struggle to remain on treatment, leaving symptoms inadequately controlled and reinforcing the need for more effective therapeutic options.
Lead author Derek Louie, PharmD, MS, Director of Health Outcomes and Economic Research at Definium Therapeutics, noted that high rates of switching, discontinuation, and prolonged treatment gaps become even more challenging because GAD frequently coexists with major depressive disorder, complicating long-term disease management.
Large real-world analysis informs future treatment development
The study analyzed de-identified U.S. pharmacy and medical claims from approximately 120 million insured individuals. Adults aged 18 years or older were identified using ICD-10 code F41.1 and followed for up to 24 months to assess treatment persistence, discontinuation, switching, and combination therapy.
The investigators acknowledged that claims data cannot capture all clinical factors influencing treatment decisions and did not distinguish patients with GAD alone from those with coexisting psychiatric disorders.
Definium said the findings provide important real-world evidence on current treatment patterns and reinforce the need for therapies that deliver faster symptom improvement, sustained efficacy, and better tolerability for patients living with generalized anxiety disorder.
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About the Writer
Fariha Sameen, PharmD (LinkedIn), is a clinical pharmacy professional with hands-on experience in patient counselling, medication review, therapeutic monitoring, and clinical documentation across multiple departments. She has experience identifying and assessing drug-related problems and supporting medication safety practices. Her interests include pharmacovigilance, ADR reporting, clinical research, and medical writing focused on clear, evidence-based communication.