Spravato has been approved since 2019 for TRD, with its label extended the following year as a rescue therapy for adults with major depressive disorder (MDD) who were at risk of self-harm or suicide.

Credit: 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.

Major depressive disorder (MDD) is characterised by characterised by depression and inability to feel pleasure. Credit: Justin Paget via Getty Images. Johnson & Johnson’s (J&J) nasal spray Spravato ...

Johnson & Johnson’s (J&J) nasal spray Spravato (esketamine) has received a label expansion, now approved as a monotherapy treatment for major depressive disorder (MDD) in adults who do not ...

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.

21, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) for SPRAVATO ...

Spravato is classified as a Schedule III controlled substance and is only available through a restricted program called the Spravato REMS. The Food and Drug Administration (FDA) has approved ...

WEDNESDAY, Jan. 22, 2025 (HealthDay News) -- 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 ...

Johnson & Johnson has priced its new Spravato nasal spray for treatment-resistant depression (TRD) too high to offer value for money, says a US cost-effectiveness body. The Institute for Clinical ...

Already on its way to becoming a blockbuster drug, Johnson & Johnson’s Spravato has received another potential boost as the FDA has blessed the nasal spray to be used as a monotherapy for major ...

Spravato is the first monotherapy for adults ... for adults with treatment-resistant major depressive disorder. Image: Adobe Stock “Treatment-resistant depression can be very complicated ...