About SPRAVATO®
If you have tried medication and therapy to help with your depression, but none of them helped, SPRAVATO® (esketamine) nasal spray is a new depression medication and the first nasal spray medication specifically for adults with treatment-resistant depression who have tried antidepressants and augmentations but have not had success in symptom relief.
SPRAVATO® (esketamine) nasal spray is indicated for the treatment of:
- Treatment-resistant depression (TRD) in adults as monotherapy or in conjunction with an oral antidepressant.
- Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant.
The U.S. Food & Drug Administration approved SPRAVATO® on March 5, 2019, and is only available to patients at certified treatment centers in the United States, such as Rochester Center for Behavioral Medicine (RCBM).
This treatment is approved for adults ages 18 and older.
SPRAVATO® is available only through a restricted distribution program called the SPRAVATO® REMS (Risk Evaluation and Mitigation Strategy). A REMS program is in place to ensure the safety of all patients treated with SPRAVATO®. The Rochester Center for Behavioral Medicine’s SPRAVATO® Program operates under the REMS program for service implementation at our office.
The goals of the REMS are to mitigate the risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO® administration and abuse and misuse of SPRAVATO® by ensuring SPRAVATO® is only dispensed and administered to patients in medically supervised healthcare settings that monitor these patients, ensuring pharmacies and healthcare settings that dispense SPRAVATO® are REMS certified, ensuring patients are informed about serious adverse outcomes from dissociation and sedation and the need for monitoring, and enrolling all patients who receive treatment in an outpatient healthcare setting in a REMS registry to characterize the risks further and support safe use.
