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Spravato FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 7, 2021.

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

Aug  3, 2020Approval  FDA Approves Spravato (esketamine) CIII Nasal Spray to Treat Depressive Symptoms in Adults with Major Depressive Disorder with Acute Suicidal Ideation or Behavior
Mar  5, 2019Approval  FDA Approves Spravato (esketamine) Nasal Spray for Treatment-Resistant Depression
Feb 12, 2019FDA Advisory Committee Recommends Approval of Spravato (esketamine) Nasal Spray for Adults with Treatment-Resistant Depression
Sep  4, 2018Janssen Submits Esketamine Nasal Spray New Drug Application to U.S. FDA for Treatment-Resistant Depression
May 31, 2018Long-Term Phase 3 Study Shows Esketamine Nasal Spray Plus an Oral Antidepressant Delayed Time to Relapse in Patients with Treatment-Resistant Depression
May  5, 2018New Phase 3 Data Show Esketamine Nasal Spray Demonstrated Rapid Improvements in Depressive Symptoms in Patients with Treatment-Resistant Depression
Apr 16, 2018Newly Published Phase 2 Study Found Esketamine Demonstrated Significantly Rapid Improvements in Depressive Symptoms and Suicidality
Jan 28, 2018Esketamine Phase 2 Data Published in JAMA Psychiatry Showed Significant Improvement of Depressive Symptoms in People with Treatment-Resistant Depression

Further information

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