The FDA has expanded the approval of Spravato, a nasal spray antidepressant, for standalone treatment of depression, which was previously contingent on combined usage with oral antidepressants. This decision follows results from a study demonstrating its effectiveness compared to a placebo. Currently, major depression affects over 20 million adults in the U.S., with a notable percentage not responding to standard treatments. Despite its approval, Spravato will be administered under strict supervision due to potential serious side effects, reflecting an emphasis on safety in treatment.
Spravato is made from esketamine, one of two mirror-image molecules found in the anesthetic ketamine, approved for standalone treatment of depression.
The FDA's decision followed a large study that revealed Spravato alone outperformed a placebo, allowing its independent use without other antidepressants.
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