FDA approves esketamine nasal spray as a standalone treatment for adults with treatment-resistant depression, offering rapid symptom relief.

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 has announced the FDA’s approval of a first-of-its-kind, esketamine nasal spray called Spravato for the standalone treatment of major depressive disorder (MDD), PTSD, and similar psychiatric conditions.

The Food and Drug Administration (FDA) recently approved the nasal spray Spravato for the treatment of major depression in people who have not responded to at least two oral antidepressants.

On Tuesday, the US Food and Drug Administration (FDA) approved Johnson & Johnson's hallucinogenic drug esketamine (brand name Spravato) nasal spray as a "monotherapy" treatment for major depressive disorder.

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 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 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 (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.

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.

The expanded indication allows esketamine nasal spray to be used as a standalone treatment in adults with MDD who have not responded to at least two oral antidepressants.