Johnson & Johnson Reports sNDA Submission of Spravato to the US FDA for Treatment-Resistant Depression
Shots:
- Johnson & Johnson has submitted sNDA of Spravato (esketamine) CIII nasal spray monotx. to the US FDA for treating adults with treatment-resistant depression (TRD)
- The submission was based on extensive data from 31 clinical trials and a real-world P-IV (TRD4005) study carried out for >5yrs. assessing the safety & efficacy of Spravato alone
- Study demonstrated a change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score within 24hrs. of Spravato administration that sustained through 4wks.; safety profile aligned with the existing results, in addition to an oral antidepressant, without any new concerns
Ref: Johnson & Johnson | Image: Johnson & Johnson
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
