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,

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.

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 U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson's nasal spray, Spravato (esketamine), as the first standalone therapy for adults suffering from major depressive disorder (MDD) who have not responded adequately to at least two oral antidepressants.

Johnson & Johnson’s (J&J) nasal spray Spravato (esketamine) has received a label expansion, now approved as a monotherapy treatment for major depressive disorder (MDD) in adults who do not respond to two oral antidepressants.

The U.S. Food and Drug Administration expanded approval for Johnson & Johnson's nasal spray, Spravato, to allow it to be used as a standalone treatment for patients with severe depression, the company said on Tuesday.

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.

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.

The U.S. Food and Drug Administration has approved a nose spray to help treat depression, Johnson & Johnson announced Tuesday.

The U.S. Food and Drug Administration approved Johnson & Johnson's ketamine-based nasal spray Spravato to treat adults with major depressive disorder, the company said on Tuesday. The approval paves the way for use of Spravato in patients whose disease has stopped responding to at least two oral anti-depressants.

The FDA says esketamine, an antidepressant derived from the anesthetic and party drug ketamine, can now be prescribed on its own. It was approved in 2019 to treat severe depression.