In Biggest Advance for Depression in Years, FDA Approves Novel Treatment for Hardest Cases
The drug, a nasal spray called esketamine acts within hours, rather than weeks or months as is typical for current antidepressants, and could offer a lifeline to about 5 million people in the United States with major depressive disorder who haven’t been helped by current treatments.
The label for the drug will carry a black box warning – the most serious safety warning issued by the FDA. It will caution users they could experience sedation and problems with attention, judgment and thinking, and that there’s potential for abuse and suicidal thoughts. People who take esketamine will have to be monitored for at least two hours after receiving a dose to guard against some of these side effects.
Older antidepressants target the neurotransmitters serotonin, norepinephrine or dopamine. Esketamine affects the receptor for a different brain chemical called glutamate.