The US Food and Drug Administration (FDA) has approved the extended use of Johnson & Johnson’s Spravato nasal spray for the treatment of patients with severe depression. From now on, the drug can be used as an independent remedy, informs Reuters.
Spravato, based on ketamine, was first approved by the FDA in 2019 as an adjunct to traditional antidepressants. Later, its use was allowed for patients with suicidal thoughts or intentions.
The expansion was made possible by the results of clinical trials that showed a rapid and significant improvement in the condition of patients treated with Spravato compared to those who received a placebo. More than 20% of participants who used this spray achieved remission. The drug affects the neurotransmitter glutamate, which plays an important role in brain function. However, the mechanism of its antidepressant action remains unclear.
Depression is one of the most common mental disorders in the world, which, according to the World Health Organization, affects about 280 million people. In the US, according to statistics from the National Institutes of Health, in 2021, more than 21 million adults had at least one episode of depression.
At the same time, about a third of patients do not respond to traditional oral antidepressants. Spravato’s new stand-alone status could be an important solution for such patients, offering a more personalized approach to treatment.
