CIII nasal spray, marking the first monotherapy to be approved for adults with treatment-resistant depression (TRD). According to the company, approval was supported by a pivotal placebo-controlled study in which Spravato demonstrated rapid and superior improvements in depressive symptoms as early as 24 hours,

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 (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.

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 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.

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

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.

The U.S. Food and Drug Administration has approved Spravato (esketamine) CIII nasal spray for adults living with major depressive disorder who have had an inadequate response to at least two oral antidepressants,

CIII nasal spray for adults living with major depressive disorder who have had an inadequate response to at least two oral antidepressants, according to a news release issued by Johnson & Johnson.

The US Food and Drug Administration has approved a new nasal spray for depression treatment. Known as Spravato and manufactured by Johnson & Johnson, this ketamine-based drug has been approved as a standalone treatment for major depressive disorder or MDD.

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.