Spravato Approval History

Reviewed by J.Stewart BPharm. Last updated on Mar 5, 2019.

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, Major Depressive Disorder

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 use in adults with treatment-resistant depression.

• Spravato uses the first new mechanism of action in decades to treat major depressive disorder.
• Spravato nasal spray is self-administered by patients under the supervision of a health care professional. Patients must be monitored for at least two hours after receiving a dose. The spray cannot be taken home.
• Because of the potential for abuse and misuse of the drug, it is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy (REMS).
• The Spravato product label carries a Boxed Warning that cautions that patients are at risk for sedation and difficulty with attention, judgment and thinking (dissociation), abuse and misuse, and suicidal thoughts and behaviors after administration of the drug.
• 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 History and FDA Approval Process for Spravato

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

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