12:31 PM EST, 01/21/2025 (MT Newswires) -- Johnson & Johnson ( JNJ ) said Tuesday that the US Food and Drug Administration approved nasal spray Spravato as the first-ever stand-alone therapy for major depressive disorder.

The product, which targets the glutamate neurotransmitter in the brain, can now be used by adults living with psychiatric disorders and who have had an inadequate response to at least two oral antidepressants, the healthcare products conglomerate said.

"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," said Bill Martin, global therapeutic area head of neuroscience at Johnson & Johnson Innovative Medicine.

The spray will be available through a restricted program due to potential risks, the company said.

The FDA approval is based on results from the pharmaceutical giant's clinical trial, which demonstrated a "rapid and superior improvement" in depressive symptoms in patients versus placebo, Johnson & Johnson ( JNJ ) said. At week four, about 22.5% of patients taking the spray achieved remission, according to the company.

In 2019, the FDA approved Spravato in conjunction with an oral antidepressant.

Johnson & Johnson ( JNJ ) reported in October that Spravato's worldwide sales grew to $284 million in the third quarter from $183 million in the year-ago period. The spray logged revenue of $243 million in the US in the 2024 third quarter.

The company is scheduled to report its fourth-quarter results on Wednesday. Analysts polled by FactSet expect the group to report sales of $22.45 billion for the December quarter.

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