Esketamine Approved by FDA as First Monotherapy for Treatment-Resistent Depression
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.
FDA-Approved Nasal Spray For Depression Is First Of Its Kind
A ketamine-based nasal spray is officially the first and only standalone therapy available for treatment-resistant depression in the US. The FDA first approved the Johnson & Johnson drug, called Spravato (esketamine),
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,
SPRAVATO® (esketamine) approved in the U.S. as the first and only monotherapy for adults with treatment-resistant depression
Johnson & Johnson (NYSE: JNJ) announced today the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) for SPRAVATO® (esketamine) CIII nasal spray, making this innovative treatment the first and only monotherapy for adults living with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants.
FDA Expands Approval of Esketamine for Depression
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.
FDA approves Spravato as monotherapy for adults with major depressive disorder
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.
FDA Approves Esketamine Nasal Spray for Treatment-Resistant Depression
The FDA has approved esketamine (Spravato) nasal spray as a monotherapy for adults with treatment-resistant depression. This approval applies to individuals who have had an inadequate response
FDA approves first-of-its-kind nasal spray for severe depression
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.
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,
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 ketamine-derived nasal spray for depression as standalone treatment
The announcement was welcome news for those with major depressive disorder, affecting an estimated 8.3% of the adult population.
mic1d
A Nasal Spray For Depression? FDA Gives Its Approval
The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson's nasal spray, Spravato (esketamine), as the first ...
BioSpace1d
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 ...
Johnson & Johnson Q4 Earnings: Cancer Drugs Performance Drives Revenue Beat, Issues Strong FY25 Outlook
Johnson & Johnson (NYSE:JNJ) reported a fourth-quarter adjusted EPS of $2.04, down 10.9% year over year, beating the ...
Psychology Today13h
Monica Johnson Psy.D.
Monica Johnson, Psy.D., is a clinical psychologist and owner of Kind Mind Psychology, a private practice in NYC that specializes in evidenced-based approaches to treating a wide range of mental ...
pharmaphorum5d
J&J builds case for antidepressant Spravato with head-to-head trial
Johnson & Johnson's Spravato therapy for treatment ... the drugmaker added to the evidence behind Spravato – an intranasal formulation of esketamine – with the release of top-line data from ...
BioSpace1d
J&J Says Deals Likely to Shrink After $14.6B Intra-Cellular Buy
On the company’s Q4 earnings call where an eyepopping $88.8 billion in full-year sales were revealed, leaders shifted focus ...
Rihanna Mourns ‘Fairy Godmother’ Star After Skiing Tragedy
World-renowned musician and businesswoman Rihanna says she is heartbroken after the shocking death of Bling Empire: New York ...
pharmaphorum3d
J&J’s Spravato for depression ‘should be much cheaper’
Johnson & Johnson has priced its new Spravato ... has published its final report on Spravato (esketamine) and says the drug would need to be between 25% and 52% cheaper to meet its value ...