Esketamine (Spravato; Johnson & Johnson) is now the first and only monotherapy for adults with major depressive disorder (MDD) with inadequate response to at least 2 oral antidepressants.

The FDA approved esketamine (Spravato) nasal spray as monotherapy for adults with treatment-resistant depression who had an inadequate response to at least two oral antidepressants, maker Johnson & Johnson announced on Tuesday.

Johnson & Johnson (NYSE: JNJ) announced today the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) for SPRAVATO® (esketamine) CIII nasal spray, making this innovative treatment the first and only monotherapy for adults living with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants.

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.

The FDA has approved esketamine (Spravato) nasal spray as a monotherapy for adults with treatment-resistant depression. This approval applies to individuals who have had an inadequate response

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.

On Tuesday, the FDA approved Johnson & Johnson’s (NYSE:JNJ) supplemental New Drug Application for Spravato (esketamine) CIII nasal spray. The approval makes the treatment the first and only monotherapy for adults living with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants.

Johnson & Johnson's Q4 sales hit $22.52 billion, with strong growth in MedTech and oncology. 2025 guidance shows promising EPS and revenue forecasts.

The announcement was welcome news for those with major depressive disorder, affecting an estimated 8.3% of the adult population.

The Food and Drug Administration has approved Johnson & Johnson's nasal spray Spravato (esketamine) as a standalone treatment for adults with treatment-resistant depression. This landmark decision makes Spravato the first-ever monotherapy of its kind,