J&J: FDA approves Spravato spray for depression
(CercleFinance.com) - Johnson & Johnson announces that the FDA has approved a supplemental application for Spravato (esketamine) nasal spray, as the first monotherapy for adults with major depression (MDD) resistant to at least two oral antidepressants.
This approval is based on a clinical study that showed rapid and significant improvement in depressive symptoms with Spravato alone, including remission for 22.5% of patients in 4 weeks, compared with 7.6% with placebo.
The safety profile is in line with existing data, but its use is restricted via the REMS program to manage risks associated with serious side effects.
According to J&J, Spravato offers an alternative for patients whose options were limited, with visible results as early as 24 hours.
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This approval is based on a clinical study that showed rapid and significant improvement in depressive symptoms with Spravato alone, including remission for 22.5% of patients in 4 weeks, compared with 7.6% with placebo.
The safety profile is in line with existing data, but its use is restricted via the REMS program to manage risks associated with serious side effects.
According to J&J, Spravato offers an alternative for patients whose options were limited, with visible results as early as 24 hours.
Copyright (c) 2025 CercleFinance.com. All rights reserved.