CIII allows people who have tried at least two oral antidepressants to use the spray on its own – without the need for more medication.
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.
Fact checked by Nick Blackmer The Food and Drug Administration (FDA) has expanded its approval of a ketamine nasal spray, Spravato (esketamine), as a standalone therapy for adults with treatment-resistant depression.
FDA approves esketamine nasal spray as a standalone treatment for adults with treatment-resistant depression, offering rapid symptom relief.
Here's what MDs want you to know about Spravato, the latest FDA-approved standalone nasal spray for depression.
A ketamine-based nasal spray is officially the first and only standalone therapy available for treatment-resistant depression in the US.
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.
Share on Pinterest The FDA has approved an esketamine nasal spray for the treatment of depression cases that do not respond to other therapeutic approaches. Image credit: Koldunov/Getty Images.
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.
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.
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.