Fact checked by Nick Blackmer The Food and Drug Administration (FDA) has expanded its approval of a ketamine nasal spray, Spravato (esketamine), as a standalone therapy for adults with treatment-resistant depression.

Here's what MDs want you to know about Spravato, the latest FDA-approved standalone nasal spray for depression.

The approval of Spravato for the monotherapy indication in TRD was supported by data from the randomized, double-blind, placebo-controlled, phase 4 TRD4005 trial.

The Food and Drug Administration has approved the first-ever stand-alone nasal spray to treat drug-resistant depression. Johnson & Johnson's Spravato was approved to treat a major depressive disorder,

The Food and Drug Administration has approved Johnson & Johnson's nasal spray as a standalone treatment for severe forms of depression, officials said. The FDA granted approval to Spravato (esketamine) as the first monotherapy for adults with treatment-resistant depression,

The FDA has approved a supplemental new drug application for Spravato, an esketamine nasal spray that can be used as monotherapy for adults with treatment-resistant depression, Johnson & Johnson announced in a press release.

Esketamine, the active ingredient in Spravato, is a non-selective, non-competitive antagonist of the NMDA receptor, a known target in depression. Since its initial approval in 2019, Spravato has become one of J&J’s high-growth brands, surging around 55% year-over-year in the third quarter of 2024 to bring in $284 million worldwide.

One-third of folks with major depressive disorder experience treatment-resistant depression (TRD), a condition that makes it more difficult to be treated by traditional oral antidepressants.