Leo Sher, M.D.
On March 5, 2019, the U.S. Food and Drug Administration (FDA) approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medications but did not improve. Because of the risk of serious side effects related to sedation and dissociation caused by esketamine administration, and the potential for abuse and misuse of the drug, it will only be available through a controlled distribution system. Healthcare providers will have to monitor patients for at least 2 hours after each time they use the spray.
Esketamine is the s-enantiomer of ketamine and a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist. To a lesser extent, esketamine prevents the reuptake of dopamine. Esketamine increases glucose metabolism in frontal cortex. This is the first FDA approval of esketamine for any use.
- FDA News Release. FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic. URL: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm632761.htm