SPRAVATO® (esketamine) CIII nasal spray is a nonselective, noncompetitive antagonist of the N-methyl-D-aspartate (NMDA) receptor – an ionotropic glutamate receptor. It is a first-of-its kind medicine approved by the FDA in two major depressive disorder (MDD) subpopulations with high unmet need.
SPRAVATO® is approved in the United States, in conjunction with an oral antidepressant, to treat adults with treatment resistant depression (TRD) and to treat depressive symptoms in adults with MDD with acute suicidal ideation or behavior.
Limitations of Use
- The effectiveness of SPRAVATO® in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Use of SPRAVATO® does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO®.
- SPRAVATO® is not approved as an anesthetic agent. The safety and effectiveness of SPRAVATO® as an anesthetic agent have not been established. SPRAVATO® (esketamine) CIII Nasal Spray While SPRAVATO® and ketamine are chemically related, SPRAVATO® is not the same as IV ketamine. Only SPRAVATO® has undergone extensive controlled clinical trials that informed the FDA approval of the medicine for use in adults with TRD and to treat depressive symptoms in adults with MDD with acute suicidal ideation or behavior.
About the SPRAVATO® Risk Evaluation & Mitigation Strategy (REMS)
SPRAVATO® is available only through a restricted distribution program called the SPRAVATO® REMS. A REMS program is in place to ensure the safety of all patients who are treated with SPRAVATO®. 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
- Enrolling all patients who receive treatment in an outpatient healthcare setting in a REMS registry to further characterize the risks and support safe use
Patients’ first visit may be a consultation to discuss the details with a healthcare provider at the certified SPRAVATO® treatment center to determine if SPRAVATO® is considered an appropriate treatment option. If SPRAVATO® is recommended, the healthcare provider will discuss important safety risks and enroll patients in the SPRAVATO® REMS Program prior to treatment initiation.