The announcement was welcome news for those with major depressive disorder, which affects an estimated 8.3% of the adult population.
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.
Johnson & Johnson's ketamine-derived nasal spray has been approved as a standalone treatment to fight depression for those who had an inadequate response to oral antidepressants.
CIII allows people who have tried at least two oral antidepressants to use the spray on its own – without the need for more medication.
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.
JNJ stock reporting earnings, expecting $2 EPS and $22.44B revenue, approval for Spravato, mixed chart signals, $167.71 price target - 13% upside
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.
The Food and Drug Administration has approved the first-ever stand-alone nasal spray to treat drug-resistant depression. Johnson & Johnson's Spravato was approved to treat a major depressive disorder,
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 approval of Spravato for the monotherapy indication in TRD was supported by data from the randomized, double-blind, placebo-controlled, phase 4 TRD4005 trial.
(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.
Spravato is now the first-ever stand-alone therapy for treatment-resistant depression, and is on its way to becoming a blockbuster product.