FDA Approves Esketamine Nasal Spray for Resistant Depression

Esketamine nasal spray gets FDA approval as a monotherapy for resistant depression, ensuring rapid relief in just 24 hours for many patients.

The US Food and Drug Administration (FDA) has approved the use of esketamine nasal spray as a standalone treatment for adults with major depressive disorder (MDD) who have not responded adequately to at least two oral antidepressants. This decision expands the indication of esketamine, offering new hope for patients with treatment-resistant depression().

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‘Esketamine nasal spray can provide relief from depression in as little as 24 hours! #mentalhealth #medindia ’

Esketamine for Treatment-Resistant Depression

Esketamine, a derivative of ketamine, is a rapid-acting antidepressant. Previously, it was approved in combination with oral antidepressants for individuals with treatment-resistant depression. With this new approval, esketamine can now be used on its own, without the need for concurrent oral antidepressant therapy.

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Clinical Evidence Supporting Approval

The expanded use of esketamine nasal spray as monotherapy is based on a randomized, double-blind, placebo-controlled trial. The study demonstrated significant improvement in depressive symptoms measured using the Montgomery-Asberg Depression Rating Scale (MADRS). At the 4-week mark:

22.5% of patients receiving esketamine achieved remission (MADRS score ≤ 12).
In comparison, only 7.6% of patients on placebo achieved remission.

These findings highlight the drug's rapid and effective antidepressant properties, providing symptomatic relief as early as 24 hours in some patients.

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Benefits of Monotherapy Use

Healthcare providers now have greater flexibility to tailor treatment plans, utilizing esketamine nasal spray alone for patients who require alternative therapeutic approaches. This approval ensures that patients with resistant depression can experience relief without the need for daily oral antidepressants, which may not be effective for them.

The safety profile of esketamine as monotherapy is consistent with its use alongside oral antidepressants. However, esketamine is associated with potential risks, including:

Sedation
Dissociation
Potential for abuse or misuse

Due to these risks, the drug is available only through a restricted distribution system under the FDA's Risk Evaluation and Mitigation Strategy (REMS). This ensures that patients are closely monitored during treatment to manage potential side effects and adverse outcomes.

The approval of esketamine nasal spray as a standalone option represents a significant advancement in the treatment of resistant depression. It provides healthcare providers with an innovative approach to managing one of the most challenging mental health conditions, improving patients' quality of life and offering a pathway to faster remission.

Reference:

FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic - (https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified)

Source-Medindia

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