Janssen: CHMP Recommends Expanded Use Of SPRAVATO - Quick Facts

(RTTNews) - The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the expanded use of SPRAVATO for the rapid reduction of depressive symptoms in a psychiatric emergency for patients with major depressive disorder. The European marketing authorisation application was based on the phase 3 double-blind, randomised, placebo controlled, multicentre ASPIRE I & II clinical studies conducted across Europe.

Esketamine nasal spray was approved by the European Commission for use in combination with a selective serotonin reuptake inhibitor or serotonin and norepinephrine reuptake inhibitor, in adult patients with treatment-resistant major depressive disorder in December 2019.