Treatment · United States
FDA approves Spravato as monotherapy for treatment-resistant depression
Esketamine nasal spray can now be used without a co-prescribed oral antidepressant, a small but consequential label change.
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The supplemental approval is narrow on paper but significant in practice: Spravato (esketamine), which was originally approved in 2019 only as an add-on to oral antidepressants, can now be prescribed on its own for adults with treatment-resistant depression.
Healio's coverage walks through the pivotal data Janssen submitted and what the change means for the in-clinic REMS-administered care model that has grown up around the drug. It also notes the cost and access barriers that have kept esketamine out of reach for many patients despite its efficacy signal.
Read Healio's full report for the trial design and clinician reactions.
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