FDA, Johnson & Johnson and major depressive disorder

Johnson & Johnson ketamine-derived nasal spray gets FDA approval for depression, but JNJ stock dips on earnings
Spravato is now the first stand-alone therapy for treatment-resistant depression, for patients who haven’t responded to oral antidepressants. On Tuesday, the Food and Drug Administration (FDA) approved Johnson & Johnson’s nasal spray,
FDA Approves Johnson & Johnson’s Spravato for Treatment-Resistant Depression
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,
J&J’s Spravato Makes Headway in Tough Depression Space With Monotherapy Approval
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.
FDA approves Johnson & Johnson’s ketamine-derived nasal spray for depression as stand-alone treatment
The announcement was welcome news for those with major depressive disorder, which affects an estimated 8.3% of the adult population.
Can a Nasal Spray Really Help Treat Depression? Here's What to Know About Spravato
Here's what MDs want you to know about Spravato, the latest FDA-approved standalone nasal spray for depression.
FDA Approves Spravato Nasal Spray for Treatment-Resistant Depression
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,
FDA Approves Johnson & Johnson's Spravato as Standalone Treatment for Depression
The Food and Drug Administration has approved Johnson & Johnson's nasal spray Spravato (esketamine) as a standalone treatment for adults with treatment-resistant depression. This landmark decision makes Spravato the first-ever monotherapy of its kind,
FDA approves antidepressant nasal spray | Morning in America
The FDA has approved the use of Spravato, an antidepressant nasal spray, as a standalone treatment for depression in the U.S. Sue Varma discusses why she supports the use of the drug and how it may help those suffering from depression.
Monthly Prescribing Reference5d
Spravato Approved as Monotherapy for Treatment-Resistant Depression
The approval of Spravato for the monotherapy indication in TRD was supported by data from the randomized, double-blind, ...
Verywell Health on MSN1d
Spravato Nasal Spray Can Now Be Used Alone for Treatment-Resistant Depression
People with treatment-resistant depression can now take Spravato's ketamine-derived nasal spray as a standalone treatment.
FiercePharma8d
Johnson & Johnson's Spravato gains FDA nod to be used as a monotherapy
Already on its way to becoming a blockbuster drug, Johnson & Johnson’s Spravato has received another potential boost as the ...
Johnson & Johnson Gets FDA OK For Spravato as Monotherapy
J&J on Tuesday said the green light makes Spravato the first and only monotherapy for adults with major depressive disorder who have had an inadequate response to at least two oral antidepressants.
Benzinga.com8d
FDA Approves Johnson & Johnson's Treatment As First Monotherapy For Treatment-Resistant Depression
FDA approves Spravato as the first monotherapy for adults with major depressive disorder unresponsive to two oral ...