The FDA has approved a new way to use Spravato, a nasal spray that helps people with severe depression. Now doctors can prescribe it by itself, instead of requiring patients to take it with daily antidepressant pills.
This matters because regular antidepressants don’t work well for many people. Out of 21 million Americans with severe depression, about one-third don’t get enough relief from standard pills. These pills can also take weeks to start working and sometimes cause unwanted effects like weight gain and sexual issues.
The nasal spray works differently. “Quite often within the same day, the very next day, people can already start to feel they’re feeling somewhat better,” says Dr. Gregory Mattingly, who has treated over 6,000 patients with Spravato at his St. Louis clinic.
How It Works and Safety Steps
Unlike regular antidepressants that affect brain chemicals called serotonin, Spravato works on a different brain system called glutamate. This new approach helps explain why it can work when other treatments haven’t.
But the medicine needs careful handling. Patients can’t just pick it up at a pharmacy. They must go to special certified clinics – there are 3,000 across the U.S. After each treatment, patients stay for two hours under medical watch because the spray can cause temporary feelings of disconnection from reality or drowsiness.
Bill Martin from Johnson & Johnson, the company that makes Spravato, emphasizes why this matters: “We want to recognize that this is a medicine that treats a disease that [when] left untreated, depression is potentially fatal.”
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Real Results
The FDA based its decision on a phase four trial, which showed Spravato alone improved depressive symptoms beginning about 24 hours after treatment and lasting through at least one month. More than a fifth of patients taking Spravato went into remission.
So far, 140,000 people worldwide have used Spravato since it first became available in 2019. The treatment has been successful enough that sales reached $780 million in just nine months of 2024. Johnson & Johnson expects annual sales will increase to between $1 billion and $5 billion.
This new approval gives doctors more flexibility to create treatment plans that work best for each person. Patients now have the choice to use the spray with or without daily pills, especially if those pills aren’t helping or are causing problems.
For anyone having thoughts of suicide or feeling severely depressed, help is available 24/7 at the Suicide & Crisis Lifeline by calling or texting 988.