Spravato: First Monotherapy FDA Approved for Treatment-Resistant MDD

Treatment-resistant depression (TRD) remains a significant challenge for clinicians and patients alike, often requiring innovative strategies beyond traditional antidepressants. A groundbreaking step in addressing this unmet need came with the FDA approval of SPRAVATO® (esketamine) nasal spray as the first monotherapy specifically for adults with TRD

SPRAVATO® was initially approved by the FDA in March 2019 as an adjunct therapy for adults with TRD. In 2025, the FDA extended its approval to include monotherapy for adults with TRD, based on robust clinical evidence demonstrating its efficacy and safety. This marked a pivotal moment, as SPRAVATO® became the first monotherapy specifically designed for TRD.

WATCH FOLLOWING YOUTUBE VIDEO FOR DETAILS:

The video has summarized this topic in following sections:

  1. Esketamine FDA Approval History.
  2. FDA Indications
  3. When to Avoid?
  4. How to Dose?
  5. Clinical Study Supporting the Approval.
  6. Common Adverse Events

Here is one slide from above presentation, on how to dose this medication:

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