FDA approves nasal spray for treatment-resistant depression

The U.S. Food and Drug Administration has approved Spravato (esketamine) CIII nasal spray for adults living with major depressive disorder who have had an inadequate response to at least two oral antidepressants, according to a news release issued by Johnson & Johnson.

Spravato is the first and only approved monotherapy for adults with refractory major depressive disorder. Approval of Spravato, granted following FDA priority review, was based on the results of a randomized, double-blind, multicenter, placebo-controlled trial.

On day 28 of the trial, patients taking Spravato exhibited numerical improvements for all 10 items on the Montgomery-Asberg Depression Rating Scale (MADRS). After four weeks, 22.5% of patients taking Spravato achieved remission (score ≤12 on MADRS) compared with 7.6% of patients taking placebo.

Spravato nasal spray is administered by the patient under the supervision of a health care provider in a health care setting. Spravato targets the neurotransmitter glutamate; however, the mechanism by which esketamine exerts its antidepressant effect is unknown.

In an effort to ensure the safe and appropriate use of Spravato, the medication is only available through a restricted program called the Spravato Risk Evaluation and Mitigation Strategy Program. This is due to the risks for serious adverse outcomes resulting from sedation, dissociation, respiratory depression, abuse, and misuse.

“Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them. For too long, health care providers have had few options to offer patients much-needed symptom improvement,” Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine, said in a statement.

“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.”

Approval of Spravato was granted to Johnson & Johnson.

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