EU approves expanded use of Janssen’s Spravato
9th February 2021
Spravato (esketamine nasal spray) is to be co-administered with oral antidepressant therapy in the specified patient population.
The approval was based on data from the Phase III ASPIRE I & II clinical studies, which compared the efficacy and safety of Spravato in combination with comprehensive standard of care (SOC) to placebo nasal spray plus comprehensive SOC in adults with moderate-to-severe MDD and current/active suicidal ideation with intent.
The primary efficacy measure across each study was the reduction of symptoms of MDD, as measured by the change from baseline Montgomery-Åsberg Depression Rating Scale (MADRS) total score at 24 hours after the first dose.