Announcement • Jul 14
Definium Therapeutics, Inc. Announces Results from New Healthcare Claims Study of Treatment Patterns of Newly Diagnosed and Established Gad Patients, Including Pharmacotherapy Use, Discontinuation, Switching and Treatment Progression
Definium Therapeutics, Inc. announced results from a new healthcare claims study of treatment patterns of newly diagnosed and established GAD patients, including pharmacotherapy use, discontinuation, switching and treatment progression. The findings, published in CNS Spectrums, highlight the challenges in achieving response and sustained remission with existing treatments and underscore the need for new GAD treatments that provide better efficacy, rapid onset, sustained symptom control, and improved tolerability. The study highlights substantial unmet need in GAD treatment, revealing frequent treatment discontinuation, switching, and prolonged gaps in care that often occur well before the 6–12 months of therapy recommended in clinical guidelines to reduce relapse risk. Specifically, the analysis found: 55% of newly diagnosed patients discontinued their initial pharmacotherapy, and 28% added or switched treatment. Among established patients, 16% discontinued and 55% added or switched treatment. Treatment changes were rapid: newly diagnosed patients switched at a median of 31 days and initiated combination therapy at 49 days, whereas established patients switched at 42 days and initiated combination therapy at 32 days. Median time to discontinuation was 84 days (newly diagnosed) and 119 days (established), both shorter than recommended in clinical guidelines. 57% of newly diagnosed patients who discontinued did not resume therapy during the study period. Among patients restarting after discontinuation, median treatment gap was 146 days (newly diagnosed) and 96 days (established). Among patients who modified their initial treatment, 75% of newly diagnosed and 94% of established patients experienced at least one additional therapy change within 12 months. Real-world data analysis revealed high rates of pharmacotherapy switching, discontinuation, and prolonged gaps in care among patients with GAD. These challenges are compounded by GAD's frequent co-occurrence with major depressive disorder, further complicating treatment management. Together, these findings underscore the urgent need for new treatment options that address both conditions. GAD remains one of the most common psychiatric disorders, characterized by excessive and persistent worry that can significantly impair daily functioning and quality of life. There has been little innovation in the treatment of GAD in the past several decades, with the last new drug approval occurring in 2007. Even with available treatment options, many patients do not achieve adequate or sustained symptom relief, and many experience adverse effects such as weight gain and sexual dysfunction, contributing to ongoing clinical and societal burden. Despite the substantial burden of GAD, treatment guidance remains fragmented. The absence of consensus-based algorithms creates uncertainty regarding when to initiate and how to sequence treatments. As of 2026, no formal comprehensive clinical practice guidelines for GAD exist in the U.S. Although the American Academy of Family Physicians previously developed a practice consensus for GAD and panic disorder, its recommendations for GAD management are limited. By evaluating treatment patterns among both newly diagnosed and established GAD patients, this analysis characterizes the evolution of pharmacologic management and provides real-world insights into the effectiveness and tolerability of current treatment strategies beyond data derived primarily from randomized controlled trials. The authors note that an inherent limitation of claims analyses is that the data captured is restricted to information available in medical claims. Additionally, the analysis did not distinguish patients with GAD alone from those with comorbid psychiatric conditions, which may meaningfully influence treatment trajectories. This was a retrospective analysis of closed claims data from the Komodo Healthcare Map™ — a longitudinal, de-identified U.S. pharmacy and medical claims database comprising approximately 120 million patients across 150+ health plans, representative of the insured U.S. population. Adult patients with GAD (=18 years) were identified using ICD-10 code F41.1, requiring =2 medical claims =30 days apart, or =1 claim plus =1 GAD-related pharmacotherapy claim, between January 1, 2020 and December 31, 2024. Two cohorts were defined: newly diagnosed GAD (n=259,158) and established GAD (n=1,018,288). Treatment patterns were assessed over 24 months across four categories: discontinuation, switch, combination, and persistence.
