sNDA Submitted: Spravato as Monotherapy for Treatment-Resistant Depression

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Johnson & Johnson has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) seeking approval of esketamine (Spravato) CIII nasal spray as a monotherapy for adults with treatment-resistant depression (TRD).¹ This would the first and only monotherapy for adults with TRD.

“Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones,” said Bill Martin, PhD, Global Therapeutic Area Head of Neuroscience at Johnson & Johnson Innovative Medicine. “We’re pleased to build on the more than a decade of research reinforcing 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.”

Supporting this submission are the positive results of the phase 4 TRD4005 study that evaluated the efficacy, safety, and tolerability of Spravato as a monotherapy. The randomized, double-blind, multicenter, placebo-controlled study showed a rapid change in Montgomery-Asberg Depression Rating Scale (MADRS) total score as soon as 24 hours after the first dose. This effect was sustained through at least 4 weeks of treatment. Spravato monotherapy’s safety profile was consistent with the existing body of clinical data 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 depression symptoms for 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 FDA approved in 2019 as an intranasal device to be used along with an antidepressant for adults with treatment-resistant depression, and subsequently to be used along with an antidepressant in adults with depression from major depressive disorder with suicidal thoughts or actions," said John J. Miller, MD, Editor in Chief of Psychiatric Times. "By adding this approval to its current FDA approved indications patients would have access to Spravato, a rapidly acting antidepressant, earlier during an episode of treatment-resistant depression, and with more flexibility as to the treatment circumstances in which it could be used. The only other medication FDA approved 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 adjunct 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 seeks U.S. FDA approval of SPRAVATO® (esketamine) as the first and only monotherapy for adults with treatment-resistant depression. News release. July 22, 2024. https://www.jnj.com/media-center/press-releases/johnson-johnson-seeks-u-s-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 a 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 real-world clinical effectiveness 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