08:32 AM EDT, 07/22/2024 (MT Newswires) -- Johnson & Johnson ( JNJ ) said Monday that it has filed a supplemental new drug application with the US Food and Drug Administration for its Spravato CIII nasal spray as a monotherapy for adults with treatment-resistant depression.

The company said its application is supported by results from a phase 4 study, which showed "rapid improvement" in depressive symptoms in about 24 hours following the first dose of Spravato and sustained through four weeks of treatment.

No new safety concerns were observed, the company added.

Spravato, or esketamine, is currently approved by the FDA as part of a combination therapy with an oral antidepressant for treatment-resistant depression.

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