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Esketamine is the second drug to be approved for TRD by the FDA, following olanzapine/fluoxetine (Symbyax) in 2009. [25] [50] Other agents, like the atypical antipsychotics aripiprazole (Abilify) and quetiapine (Seroquel), have been approved for use in the adjunctive therapy of MDD in people with a partial response to treatment. [25]
An enantiomer of ketamine – esketamine commercially sold as Spravato – was approved as an antidepressant by the European Medicines Agency in 2019. [63] Esketamine was approved as a nasal spray for treatment-resistant depression in the United States [64] and elsewhere in 2019 (see Esketamine and Depression). The Canadian Network for Mood and ...
After the publication of the NIH-run antidepressant clinical trial, clinics began opening in which the intravenous ketamine is given for depression. [5] [6] This practice is an off label use of IV ketamine in the United States, though the intranasal version of esketamine has been approved by the FDA for treatment of depression [5] [7] In 2015 there were about 60 such clinics in the US; the ...
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Lykos Therapeutics is cutting 75% of staff after FDA rejected its MDMA drug for mental health. The FDA's decision marks the first time the agency considered a psychedelic for medical use.
The US Food and Drug Administration has approved the first medication for a common form of liver inflammation called nonalcoholic steatohepatitis, or NASH, the agency said Thursday.
In 2019, the FDA approved the use of esketamine (Spravato) as a nasal spray, in conjunction with an oral antidepressant, for treatment-resistant depression in adults. Potential risks associated with it include dissociation, sedation and abuse. Esketamine cannot be distributed outside of certified clinical settings. [11]
Robert F. Kennedy Jr.'s personal attorney previously petitioned the Food and Drug Administration to revoke its approval of a polio vaccine, highlighting an influential Kennedy ally who, sources ...