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GlobalData on MSNJ&J’s Spravato receives FDA label expansion for depression monotherapyJohnson & 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 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 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.
Gregory Mattingly, MD, president, Midwest Research Group, founding partner, St. Charles Psychiatric Associates, discusses the immediate impact Spravato has had on patients with treatment-resistant ...
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 ...
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