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.
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.
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.
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 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.
Here's what MDs want you to know about Spravato, the latest FDA-approved standalone nasal spray for depression.
A nasal spray therapy for treatment-resistant major depressive disorder (MDD) has now been approved by the Food and Drug Administration (FDA) for use on its own, making it the first-ever approved standalone treatment for this condition.
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.
(HealthDay News) — The US 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 2 oral antidepressants, according to a news release issued by Johnson & Johnson.
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.
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.