J&J: applies for a new indication for Spravato

(CercleFinance.com) - Johnson & Johnson announces that it has applied to the FDA for a new indication for Spravato (esketamine) nasal spray, as monotherapy for adults suffering from treatment-resistant depression (TRD).


The company emphasizes the importance of this new treatment option for patients whose symptoms are not resolved by multiple treatments.

The application is based on positive results from a Phase 4 study showing rapid improvement in depression scores as early as 24 hours after the first dose and for at least 4 weeks.

J&J recalls that Spravato is already FDA-approved, in combination with an oral antidepressant, to treat TRD and depressive symptoms with acute suicidal ideation in adults.

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