The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson’s ketamine-based nasal spray for adults with major depressive disorder.
The therapy, marketed under the name Spravato, is designed to provide rapid relief for those who have not responded to traditional antidepressants, the company said in a statement Tuesday.
Spravato, which is derived from the anesthetic ketamine, works by targeting glutamate receptors in the brain, a novel approach compared to conventional treatments that focus on serotonin or norepinephrine.
"Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them...Spravato is now available as a standalone treatment, meaning patients may experience improvements in depressive symptoms as early as 24 hours and at 28 days – without the need for daily oral antidepressants," announced Bill Martin, Ph.D., Neuroscience global therapeutic area head at Johnson & Johnson Innovative Medicine.
The nasal spray has shown promise in clinical trials, demonstrating rapid efficacy in alleviating depressive symptoms. Unlike traditional antidepressants, which can take weeks to show results, Spravato’s effects can be felt within hours. This is particularly crucial for individuals experiencing acute depressive episodes or suicidal thoughts.
According to the product label, the therapy is administered under medical supervision due to its potential side effects, which may include dizziness, dissociation, and a temporary increase in blood pressure.
The approval is being hailed as a game-changer in the treatment of depression. Experts believe it could offer new hope for millions of Americans who have struggled with treatment-resistant depression.
According to the National Institute of Mental Health (NIMH), approximately 21 million adults in the U.S. experienced at least one major depressive episode in 2021, representing 8.4% of the adult population. Of these, an estimated 14.5 million experienced episodes classified as severe, accounting for 5.7% of all U.S. adults, data from NIMH showed.
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