Data highlight the challenges of achieving response and sustained remission in newly diagnosed and established GAD patients with existing therapies

Definium Therapeutics, Inc. (NASDAQ:DFTX) ("Definium" or the "Company"), 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.

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.