The U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Johnson & Johnson’s SPRAVATO (esketamine) CIII nasal spray, making the treatment the first and only monotherapy for adults living with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants.

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

This approval, which was granted following FDA Priority Review, is supported by positive results from the randomized, double-blind, multicenter, placebo-controlled study in which SPRAVATO alone showed a rapid and superior improvement in Montgomery-Asberg Depression Rating Scale (MADRS) total score vs. placebo.

Backed by more than a decade of research and almost six years of real-world evidence, SPRAVATO has proven to be a transformational treatment option for many patients with treatment-resistant depression by reducing depression symptoms in as little as 24 hours and reducing the time to relapse for patients who stay on treatment. To date, SPRAVATO has been administered to more than 140,000 patients worldwide.

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