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GlobeNewswire·

Reviva Announces Regulatory Update Regarding the Development of Brilaroxazine for the Treatment of Schizophrenia

  • FDA pre-NDA meeting feedback recommends a second Phase 3 trial to generate additional efficacy & safety data for brilaroxazine before NDA submission for schizophrenia.
  • Current data package demonstrates long-term safety, broad-spectrum clinical activity, & favorable adherence for once-daily brilaroxazine over up to one year.
  • Reviva plans to initiate the RECOVER-2 registrational trial in H1 2026, subject to securing sufficient financing.
  • The RECOVER-2 trial design will be similar to the completed RECOVER Phase 3 trial & FDA provided guidance on data analysis, presentation, & specific study requirements.
  • Existing clinical data includes 790 subjects across Phase 2 & Phase 3 trials showing efficacy in major symptom domains & a generally well-tolerated safety profile in over 900 subjects.