Definition
Risk Evaluation and Mitigation Strategy — an FDA-required safety program for medications with serious risks. Spravato (esketamine) is administered only at REMS-certified clinics with patient observation post-dose.
Related Terms
Esketamine
The (S)-enantiomer of ketamine, FDA-approved as the nasal spray Spravato for treatment-resistant depression and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior.
Spravato
Brand name for esketamine intranasal spray, manufactured by Janssen. FDA-approved in 2019 for treatment-resistant depression; administered only in certified clinics under a Risk Evaluation and Mitigation Strategy (REMS).
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