FDA approves supplemental indication of Spravato for major depressive disorder with acute suicidal ideation or behavior. Johnson & Johnson

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the 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. Spravato is the first and only approved medicine that has been shown to reduce depressive symptoms within 24 hours, 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. 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.