FDA provides supplemental approval for Spravato (esketamine) CIII nasal spray, for adults living with major depressive disorder – Johnson & Johnson

Johnson & Johnson  announced the FDA approval of a supplemental New Drug Application (sNDA) for Spravato (esketamine) CIII nasal spray, making this innovative 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.

MDD is one of the most common psychiatric disorders, with an estimated 21 million adults in the U.S. living with the disease. About one-third of adults will not respond to oral antidepressants alone, which has a significant negative impact on the quality of life of those affected. MDD has a high economic burden, with nearly half of it attributable to treatment-resistant depression (TRD).

“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. In a post-hoc analysis, Spravato demonstrated numerical improvements across all 10 MADRS items at day 28. At week 4, 7.6% of patients taking placebo and 22.5% of patients taking Spravato  achieved remission (MADRS total score ≤ 12). The safety profile of Spravato as a standalone treatment was consistent with the existing body of clinical and real-world data when used in conjunction with an oral antidepressant, and no new safety concerns were identified.

Because of the risks of serious adverse outcomes resulting from sedation, dissociation, respiratory depression, abuse, and misuse, to facilitate safe and appropriate use, Spravato  is only available through a restricted program called the Spravato Risk Evaluation and Mitigation Strategy (REMS) Program.

“For more than six years, I’ve seen firsthand the real-world impact Spravato  can have on patients’ lives,” said Gregory Mattingly, M.D., President, Midwest Research Group and Founding Partner St. Charles Psychiatric Associates. “Now that it is also available as a monotherapy, healthcare providers have the freedom to further personalize treatment plans based on individual needs, so patients can experience the efficacy of Spravato in as little as 24 hours, through day 28, without the need for a daily oral antidepressant.”

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 TRD 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