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WASHINGTON -- The FDA approved a new indication for esketamine (Spravato): major depression with suicidal ideation or behavior, .

Previously, the drug -- given intranasally via a special device -- was OK'd for treatment-resistant depression.

Results of two phase III trials underpinned the new approval, according to Janssen, a unit of Johnson & Johnson. These studies showed that the product reduced mean Montgomery-Åsberg Depression Rating Scale scores by 15.9 and 16.0 points within 24 hours, compared with reductions of 12.0 and 12.2 points in the trials' placebo groups. (All patients also received "comprehensive standard of care" in addition to the drug or placebo.)

Notably, said Janssen, "some patients start[ed] to respond as early as four hours."

But esketamine was no more effective than placebo in reducing suicidality as measured on a standardized global scale, the company acknowledged.

Esketamine will continue to come with a boxed warning about increases in suicidal thoughts and actions in young adults (the drug is not approved for any purpose in children). An FDA-mandated risk evaluation and mitigation strategy will also remain in place, in light of esketamine's risk for sedation, dissociative thoughts, and attendant abuse potential. These are the same side effects seen with ketamine, a racemic version of the same molecule, which is used legitimately as an anesthesia agent but is also a party drug called Special K.

Controversy flared over esketamine after the FDA first approved it in March 2019. Critics accused the agency of putting too much emphasis on the drug's efficacy -- which they called modest and perhaps transient -- and not enough on its potential for adverse effects.

In announcing the expanded indication, Janssen appeared to take account of the criticism, saying the drug's rapid onset provides "a new option for significant symptom relief until a longer-term, comprehensive treatment plan can take effect." Conventional antidepressants, the firm noted, typically don't begin to show benefit for weeks after starting them.

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