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 respond to ...

Credit: Justin Paget via Getty Images. Johnson & Johnson’s (J&J) nasal spray Spravato (esketamine) has received a label expansion, now approved as a monotherapy treatment for major depressive disorder ...

Johnson & Johnson (NYSE:JNJ) announced Tuesday that the U.S. FDA approved a supplemental New Drug Application for its depression therapy Spravato (esketamine), expanding its use as a single agent ...

The label expansion is based on results from a trial that showed Spravato provided improvements over placebo in all 10 of the categories in the Montgomery-Asberg Depression Rating Scale (MADRS).

John­son & John­son’s Spra­va­to nasal spray re­ceived a la­bel ex­pan­sion on Tues­day, now ap­proved as a stand­alone treat­ment for ma­jor de­pres­sive dis­or­der in adults ...

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.

Downsides of Spravato: Spravato’s warning label cautions about the risk of sedation and dissociation, respiratory depression, suicidal thoughts, and abuse or misuse of the drug, among other ...

Spravato is the only drug derived from ketamine that is FDA-approved to treat a psychiatric condition. Some health clinics offer ketamine off-label to treat mental health conditions, including ...

Spravato was previously approved by the FDA ... also has the nickname "Special K" — but it has also been used off-label intravenously in some wellness clinics in an attempt to mitigate symptoms ...