3 August 2020 - Approval is based on Phase 3 data showing Spravato reduced depressive symptoms in as little as four hours in some patients, with symptom improvement maintained through the four week treatment period.

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. FDA has approved the supplemental new drug application for Spravato (esketamine) CIII nasal spray, taken with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behaviour.

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.

Read Janssen press release