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
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.