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 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.

An emerging treatment for clinical depression has reached an important milestone. This week, the Food and Drug Administration approved Johnson & Johnson’s ketamine-based nasal spray, Spravato, as a standalone therapy for cases of depression that haven’t responded to other options.

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 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 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.

Johnson & Johnson (NYSE:JNJ) announced Tuesday that the U.S. FDA approved a supplemental New Drug Application for its depression therapy Spravato (esketamine), expanding its use as a single agent for adults with major depressive disorder (MDD).