Janssen: FDA OKs Spravato (esketamine) CIII Nasal Spray for Depression

The Janssen Pharmaceutical Inc. Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for SPRAVATO^® (esketamine) CIII nasal spray, taken with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.¹ SPRAVATO^® is the first and only approved medicine that has been shown to reduce depressive symptoms within 24 hours,¹ providing a new option for significant symptom relief until a longer-term, comprehensive treatment plan can take effect.

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^® carries a Boxed Warning regarding a Risk Evaluation and Mitigation Strategy (REMS) and the risk of suicidal thoughts and behaviors. See below for Important Safety Information. SPRAVATO^® will be made available at REMS certified treatment centers. Janssen is working to responsibly educate and certify treatment centers in accordance with the REMS so healthcare providers can offer SPRAVATO^® to appropriate patients.

https://www.biospace.com/article/releases/janssen-announces-u-s-fda-approval-of-spravato-esketamine-ciii-nasal-spray-to-treat-depressive-symptoms-in-adults-with-major-depressive-disorder-with-acute-suicidal-ideation-or-behavior/