Johnson & Johnson is seeking approval for its SPRAVATO (esketamine) CIII nasal spray for treatment-resistant depression (TRD) with the submission of a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA).
The nasal spray is intended for use as a monotherapy in adult TRD patients.
The sNDA filing is based on the positive outcomes of the Phase IV TRD4005 study.
This randomised, multicentre, double-blind, placebo-controlled trial evaluated the efficacy, safety and tolerability of SPRAVATO as a single agent.
Results indicated a significant shift in the Montgomery-Asberg Depression Rating Scale total score within 24 hours after the initial dose, with sustained effects for at least four weeks.
SPRAVATO monotherapy’s safety profile was in line with the currently available clinical data for oral antidepressants.
No new safety concerns linked to the treatment were detected.
SPRAVATO is FDA-approved as an adjunctive treatment with an oral antidepressant for adults with TRD, and for depressive symptoms in adults with major depressive disorder (MDD) featuring acute suicidal ideation or behaviour.
The treatment has obtained regulatory approvals in 77 countries and used by over 100,000 individuals globally.
TRD impacts 30% of the estimated 280 million people globally diagnosed with MDD.
It is characterised by an insufficient response to two or more antidepressants taken orally during the same depressive episode.
Johnson & Johnson innovative medicine neuroscience global therapeutic area head Bill Martin stated: “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.
“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.”
The company recently reported a 12.8% decrease in net earnings for the second quarter (Q2) of 2024, with figures falling to $4.6bn from $5.3bn in the same period of the previous year.
