\nDefinium Therapeutics, Inc. (Nasdaq: DFTX) (\u201cDefinium\u201d or the \u201cCompany\u201d), a late-stage clinical biopharmaceutical company developing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders, today 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.<\/p>\n
\nThe 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\u201312 months of therapy recommended in clinical guidelines to reduce relapse risk. Specifically, the analysis found:<\/p>\n
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- 55%<\/b> of newly diagnosed patients discontinued their initial pharmacotherapy, and 28%<\/b> added or switched treatment. Among established patients, 16%<\/b> discontinued and 55%<\/b> added or switched treatment.\n<\/li>\n
- \nTreatment changes were rapid: newly diagnosed patients switched at a median of 31 days<\/b> and initiated combination therapy at 49 days<\/b>, whereas established patients switched at 42 days<\/b> and initiated combination therapy at 32 days<\/b>.<\/p>\n<\/li>\n
- \nMedian time to discontinuation was 84 days<\/b> (newly diagnosed) and 119 days<\/b> (established), both shorter than recommended in clinical guidelines.<\/p>\n<\/li>\n
- 57%<\/b> 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<\/b> (newly diagnosed) and 96 days<\/b> (established).\n<\/li>\n
- \nAmong patients who modified their initial treatment, 75%<\/b> of newly diagnosed and 94%<\/b> of established patients experienced at least one additional therapy change within 12 months.<\/p>\n<\/li>\n<\/ul>\n
\n\u201cGAD affects approximately 1 in 10 adults in the U.S., and our analysis shows that for many of them, current treatments simply aren\u2019t delivering with many patients struggling to remain on treatment. More than half of newly diagnosed patients who stopped therapy never restarted during the study follow-up. We can\u2019t close that gap without better options,” said Roger S. McIntyre, MD, FRCPC, co-author and Professor of Psychiatry and Pharmacology at the University of Toronto. \u201cBehind every statistic is a person who has not achieved the symptomatic relief that\u2019s meaningful for them, often leading them to stop treatment and providing impetus for us to discover innovative new treatments.\u201d<\/p>\n
\n\u201cOur real-world data analysis revealed high rates of pharmacotherapy switching, discontinuation, and prolonged gaps in care among patients with GAD,” said Derek Louie, PharmD, MS, lead author and Director of Health Outcomes and Economic Research at Definium Therapeutics. \u201cThese 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.\u201d<\/p>\n
\nGAD 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.1-3<\/sup><\/p>\n
\nDespite 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.<\/p>\n
\nThe 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.<\/p>\n
About the Study
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<\/b>This was a retrospective analysis of closed claims data from the Komodo Healthcare Map\u2122 \u2014 a longitudinal, de-identified U.S. pharmacy and medical claims database comprising ~120 million patients across 150+ health plans, representative of the insured U.S. population. Adult patients with GAD (\u226518 years) were identified using ICD-10 code F41.1, requiring \u22652 medical claims \u226530 days apart, or \u22651 claim plus \u22651 GAD-related pharmacotherapy claim, between January 1, 2020 and December 31, 2024. Two cohorts were defined: newly diagnosed GAD<\/strong> (n=259,158) and established GAD<\/strong> (n=1,018,288). Treatment patterns were assessed over 24 months across four categories: discontinuation, switch, combination, and persistence.<\/p>\nAbout Generalized Anxiety Disorder (GAD)
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<\/b>GAD is one of the most common psychiatric disorders, affecting approximately 26 million U.S. adults.4,5<\/sup> People with GAD experience constant, overwhelming worry that is hard to control. Common symptoms include fatigue, muscle tension, trouble concentrating, and difficulty sleeping.6<\/sup> GAD often occurs alongside other health problems like chronic physical symptoms, depression, other anxiety disorders, and trauma-related conditions. Together, these issues can seriously impact a person\u2019s daily life, including substantial functional, economic, and quality-of-life burdens, and are associated with increased healthcare utilization and costs.7-9<\/sup><\/p>\n\nWhile several GAD pharmacotherapies are approved, many patients do not experience sustained relief, and approximately 50% inadequately respond to first-line treatments.10<\/sup> Despite the significant personal and societal burden of GAD, there has been little innovation in the treatment of GAD in the past several decades, with the last new drug approval occurring in 2007.11<\/sup><\/p>\n
About Major Depressive Disorder (MDD)
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<\/b>Major Depressive Disorder (MDD) is the second-most common mental health disorder in the U.S., with over 21 million adults experiencing a major depressive episode (MDE) each year.12,13<\/sup> This disorder, a leading cause of disability worldwide,14<\/sup> brings persistent feelings of worthlessness, fatigue, and recurrent thoughts of death15<\/sup> while increasing long-term mortality risk by 40%.16<\/sup> MDD also carries a $326 billion annual economic burden in the U.S., driven by healthcare costs and lost productivity.17<\/sup> The MDD treatment paradigm is characterized by critical unmet needs, including fewer than one-third of patients reaching remission with first-line treatments18<\/sup>, onset of clinical activity that takes weeks to months,19,20<\/sup> poor tolerability,21,22<\/sup> and frequent switching, augmentation, and discontinuation of pharmacotherapy.23<\/sup><\/p>\nAbout Definium Therapeutics
\n
<\/b>The mission of Definium Therapeutics is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. Guided by a recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today\u2019s mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX.<\/p>\n\nFor more information, visit https:\/\/definiumtx.com\/<\/a> and follow Definium Therapeutics on Instagram<\/a>, LinkedIn<\/a> and X<\/a>.<\/p>\n
References:<\/b><\/p>\n
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- \nCascade E, Kalali AH, Kennedy SH. Real-world data on SSRI antidepressant side effects. Psychiatry (Edgemont). 2009;6(2):16-18.<\/p>\n<\/li>\n
- \nBandelow B, Michaelis S, Wedekind D. Treatment of anxiety disorders. Dialogues Clin Neurosci. 2017;19(2):93-107.<\/p>\n<\/li>\n
- \nJakubovski E, Johnson JA, Nasir M, M\u00fcller-Vahl K, Bloch MH. Systematic review and meta-analysis: Dose-response curve of SSRIs and SNRIs in anxiety disorders. Depress Anxiety. 2019;36(3):198-212.<\/p>\n<\/li>\n
- \nRingeisen, H., et al. (2023). Mental and substance use disorders prevalence study (MDPS): Findings report. RTI International and current U.S. Census data and internal company estimates.<\/p>\n<\/li>\n
- \nFerries, E., et al. The Prevalence and Burden of Generalized Anxiety Disorder in the United States Healthcare System: Real-World Prevalence and Incidence from 2020-2023. Journal of Mood and Anxiety Disorders<\/i>. 2026;13.<\/p>\n<\/li>\n
- \nPatriquin, M. A., & Mathew, S. J. (2017). The neurobiological mechanisms of generalized anxiety disorder and chronic stress. Chronic Stress<\/i>. Mar 2017;1:1-10.<\/p>\n<\/li>\n
- \nBarrera, T. L., & Norton, P. J. (2009). Quality of life impairment in generalized anxiety disorder, social phobia, and panic disorder. Journal of Anxiety Disorders<\/i>. 2009;23(8):1086\u20131090.<\/p>\n<\/li>\n
- \nArmbrecht, E., Shah, R., Poorman, G. W., et al. (2021). Economic and humanistic burden associated with depression and anxiety among adults with non-communicable chronic diseases (NCCDs) in the United States. Journal of Multidisciplinary Healthcare.<\/i> 2021;14;887\u2013896.<\/p>\n<\/li>\n
- \nNewman, M. G., Llera, S. J., Erickson, T. M., Przeworski, A., & Castonguay, L. G. (2013). Worry and generalized anxiety disorder: A review and theoretical synthesis of evidence on nature, etiology, mechanisms, and treatment. Annual Review of Clinical Psychology<\/i>, 2013;9:275\u2013297.<\/p>\n<\/li>\n
- \nAnsara, E. D. (2020). Management of treatment-resistant generalized anxiety disorder. Mental Health Clinician<\/i>, 2020;10(6): 326\u2013334.<\/p>\n<\/li>\n
- \nU.S. Food and Drug Administration. (2007, August 9). FDA approves Cymbalta for treatment of generalized anxiety disorder [Press release]. https:\/\/investor.lilly.com\/static-files\/499f0aa3-281f-49f4-9655-049aae179593<\/a>.<\/p>\n<\/li>\n
- \nNational Institute of Mental Health (NIMH). “Major Depression: Prevalence of Major Depressive Episode Among Adults.” Updated 2024.<\/p>\n<\/li>\n
- \nSubstance Abuse and Mental Health Services Administration (SAMHSA). “2023 National Survey on Drug Use and Health (NSDUH).”<\/p>\n<\/li>\n
- \nWorld Health Organization (WHO). “Depression Fact Sheet.” Updated 2023.<\/p>\n<\/li>\n
- \nAmerican Psychiatric Association. “Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).” 2013.<\/p>\n<\/li>\n
- \nCuijpers, P., et al. “Long-Term Mortality Risk in Depression: A 20-Year Follow-Up Study.” JAMA Psychiatry, 2023.<\/p>\n<\/li>\n
- \nGreenberg, P. E., et al. “The Economic Burden of Adults with Major Depressive Disorder in the United States (2020).” Journal of Clinical Psychiatry, 2024.<\/p>\n<\/li>\n
- \nRush, A. J., et al. “Acute and Longer-Term Outcomes in Depressed Outpatients Requiring One or Several Treatment Steps: A STAR*D Report.” American Journal of Psychiatry, 2006.<\/p>\n<\/li>\n
- \nAPA. \u201cPractice Guideline for the Treatment of Patients with Major Depressive Disorder.\u201d Published 2010.<\/p>\n<\/li>\n
- \nAlemi F, Min H, et al. \u201cEffectiveness of common antidepressants: A post market release study.\u201d eClinicalMedicine. 2021;41.<\/p>\n<\/li>\n
- \nCipriani A, et al. \u201cComparative Efficacy and acceptability of 21 antidepressant drugs for the Acute Treatment of Adults with Major Depressive Disorder: A Systematic Review and Network Meta-analysis.\u201d Lancet. 2018;391(10128):1357-66.<\/p>\n<\/li>\n
- \nBraund TA, Tillman G, et al. \u201cAntidepressant Side Effects and Their Impact on Treatment Outcome in People with Major Depressive Disorder: An Ispot-D Report.\u201d Transl Psychiatry. 2021;11(1):417.<\/p>\n<\/li>\n
- \nZhu L, Ferries E, et al. \u201cEconomic Burden and Antidepressant Treatment Patterns Among Patients with Major Depressive Disorder in the United States.\u201d J Manag Care Spec Pharm. 2022 Nov;28(11-a Suppl): S2-S13.<\/p>\n<\/li>\n<\/ol>\n
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View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20260714945154\/en\/<\/a><\/span><\/p>\n
Investors:
\n<\/b>
Gitanjali Jain
\n
VP, Head of Investor Relations
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ir@definiumtx.com<\/a><\/p>\n - \nPatriquin, M. A., & Mathew, S. J. (2017). The neurobiological mechanisms of generalized anxiety disorder and chronic stress. Chronic Stress<\/i>. Mar 2017;1:1-10.<\/p>\n<\/li>\n
- \nTreatment changes were rapid: newly diagnosed patients switched at a median of 31 days<\/b> and initiated combination therapy at 49 days<\/b>, whereas established patients switched at 42 days<\/b> and initiated combination therapy at 32 days<\/b>.<\/p>\n<\/li>\n
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