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Federal regulators approved Johnson & Johnson’s (NYSE: JNJ) nasal spray Spravato as the first stand-alone therapy for adults with treatment-resistant depression.

The Food and Drug Administration’s decision, announced last week, allows Spravato to be used without requiring patients to take oral antidepressants as well. The FDA previously required combination use with traditional antidepressants.

According to J&J, the treatment demonstrated superior improvement in depressive symptoms compared to placebo as quickly as 24 hours after administration, with benefits sustained through 28 days.

“Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them,” Bill Martin, global therapeutic area head of neuroscience at J&J’s Innovative Medicine unit, said in a statement.

The approval follows clinical trials where 22.5% of patients receiving Spravato achieved remission after four weeks, compared to 7.6% on placebo, according to company data.

The treatment targets glutamate, the brain’s most prevalent excitatory neurotransmitter – which prompts sharing rather than inhibiting information between neurons – representing a different mechanism than traditional antidepressants. However, the company noted the exact way it works to treat depression remains unknown.

Major depressive disorder affects approximately 21 million adults in the U.S., with roughly one-third not responding adequately to conventional antidepressants, J&J reported. The condition carries significant economic burden, particularly among treatment-resistant cases.

The drug will continue to be available only through a restricted program due to risks including sedation and potential for abuse. Patients must receive treatment at certified health care facilities where they can be monitored for at least two hours after administration.

Since its original approval nearly six years ago, Spravato has been administered to more than 140,000 patients globally, according to the company. The treatment is now approved in 77 countries.

The treatment has gained significant commercial traction, becoming Johnson & Johnson’s newest “billion-dollar brand” after surpassing $1 billion in annual sales for 2024, according to company executives. In an earnings call last Tuesday, Jennifer Taubert, J&J’s executive vice president, noted the drug’s growth of 45.3% was driven by “increased physician and patient confidence” in the treatment.

The approval comes as other companies race to develop novel treatments for depression, though some face setbacks. Compass Pathways, which is testing a psilocybin-based therapy for treatment-resistant depression, recently announced it would cut 30% of its workforce and delay key trial results to mid-2025. RBC Capital Markets analysts estimated in July that the drug could generate peak sales of $2.3 billion if approved, however the company has faced regulatory hurdles around maintaining proper blinding in psychedelic drug trials, according to company statements.