Johnson & Johnson has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of esketamine nasal spray (Spravato) CIII as monotherapy for adults with treatment-resistant depression (TRD).1 This would be the first and only monotherapy for adults with TRD.
“Many patients with difficult-to-treat depression spend too much time on multiple treatments that do not effectively resolve their symptoms, which can cause significant functional and emotional burden on patients and their loved ones,” said Bill Martin, PhD, global therapeutic area head for neuroscience at Johnson & Johnson Innovative Medicine. “We are pleased to build on more than a decade of research that reinforces the safety and efficacy of Spravato and look forward to working with the FDA to bring this innovative treatment to patients as a monotherapy option.”
This submission is supported by positive results from the Phase 4 TRD4005 study that evaluated the efficacy, safety and tolerability of Spravato as monotherapy. The randomized, double-blind, multicenter, placebo-controlled study showed a rapid change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score as early as 24 hours after the first dose. This effect was maintained for at least 4 weeks of treatment. The safety profile of Spravato as monotherapy was consistent with the existing clinical data set in combination with an oral antidepressant. No new safety concerns were identified.2 Furthermore, previous research found that esketamine nasal spray is associated with significant reductions in depressive symptoms in patients with TRD in real-world clinical settings.3.4
“Johnson & Johnson has applied to the FDA for a supplemental New Drug Application for Spravato (esketamine) to be approved as the first monotherapy for treatment-resistant depression. Spravato was approved by the FDA in 2019 as an intranasal device to be used together with an antidepressant for adults with treatment-resistant depression and subsequently to be used together with an antidepressant in adults with major depressive disorder depression with suicidal thoughts or actions,” said John J. Miller, MD, Editor-in-Chief of Psychiatric times“By adding this approval to the current FDA-approved indications, patients would have access to Spravato, a rapid-acting antidepressant, at an earlier stage of an episode of treatment-resistant depression and with more flexibility regarding the treatment circumstances in which it could be used. The only other FDA-approved medication for treatment-resistant depression is Symbyax, a fixed-combination drug containing olanzapine and fluoxetine in a capsule formulation.”
Spravato is currently FDA-approved as an add-on to oral antidepressants for the treatment of adults with TRD and depressive symptoms in adults with MDD with acute suicidal ideation or behavior.
References
1. Johnson & Johnson files for US FDA approval of SPRAVATO® (esketamine) as the first and only monotherapy for adults with treatment-resistant depression. Press release. July 22, 2024. https://www.jnj.com/media-center/press-releases/johnson-johnson-seeks-us-fda-approval-of-spravato-esketamine-as-the-first-and-only-monotherapy-for- adults with treatment-resistant depression
2. Janik A, Qiu X, Lane R, et al. SPRAVATO (esketamine nasal spray) as monotherapy for treatment-resistant depression (TRD). American Society of Psychopharmacology Annual Meeting. Poster presentation. May 28, 2024.
3. McInnes L, Joshi K, Kane G, et al. A retrospective study of the real-world clinical efficacy of esketamine nasal spray therapy among patients with treatment-resistant depression. American Society of Clinical Psychopharmacology Annual Meeting. Poster presentation. May 30, 2024.
4. O’Brien E. Efficacy of esketamine nasal spray for TRD in real-world clinical settings. Psychiatric times. May 31, 2024. https://www.psychiatrictimes.com/view/efficacy-of-esketamine-nasal-spray-for-trd-in-real-world-clinical-settings
