Spravato FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 7, 2021.
Spravato (esketamine) is a rapid acting, nasal spray formulation of a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist indicated, in conjunction with an oral antidepressant, for the treatment of treatment-resistant depression (TRD) in adults, and depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.
- Spravato uses the first new mechanism of action in decades to treat major depressive disorder.
- Because of the risks for sedation, dissociation, and abuse and misuse, Spravato is only available through a restricted program called the Spravato Risk Evaluation and Mitigation Strategy (REMS) Program.
- Spravato nasal spray is self-administered by patients under the supervision of a healthcare professional in a certified healthcare setting. Patients must be monitored for at least two hours after receiving a dose. The nasal spray cannot be taken home.
- Esketamine is the s-enantiomer of ketamine. Ketamine is a mixture of two enantiomers (mirror image molecules). The FDA first approved ketamine (Ketalar) in 1970. This is the first FDA approval of esketamine for any use.
Development Timeline for Spravato
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