Spravato FDA Approval History
Reviewed by Judith Stewart BPharm. Last updated on Aug 6, 2020.
FDA Approved: Yes (First approved March 5, 2019)
Brand name: Spravato
Generic name: esketamine
Dosage form: Nasal Spray
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Depression
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
Further information
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