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Janssen Receives Positive CHMP Opinion for Spravato® (esketamine) Nasal Spray for Adults with Treatment-Resistant Major Depressive Disorder
Oct 18, 2019 Belgium If approved by the European Commission, esketamine nasal spray will offer the first new mechanism of action in 30 years to treat major depressive disorder (MDD) In the phase III clinical development programme with flexible dosing, ...
SPRAVATO®▼ (Esketamine) Nasal Spray Approved in Europe for Adults with Treatment-Resistant Major Depressive Disorder
Dec 19, 2019 Belgium Esketamine nasal spray offers the first new mechanism of action for an antidepressant in 30 years EC approval is based on data from a clinical trial programme in adult patients with treatment-resistant major depressive disorder, ...
SPRAVATO® (Esketamine Nasal Spray) Authorised in Europe for the Rapid Reduction of Depressive Symptoms in a Psychiatric Emergency for Patients with Major Depressive Disorder
Feb 08, 2021 Belgium This milestone makes esketamine nasal spray the first N-methyl-D-aspartate (NMDA) antagonist to be approved for patients with Major Depressive Disorder (MDD) in a psychiatric emergency 1–3 European Commission (EC) authorisation is ...
Janssen Seeks Expanded Use of SPRAVATO®▼ (Esketamine) Nasal Spray in Europe as a Treatment for Depressive Symptoms in Adults with Major Depressive Disorder Who Have Current Suicidal Ideation with Intent
Jan 15, 2020 Belgium In two pivotal Phase 3 trials, SPRAVATO ® ▼ combined with comprehensive standard of care achieved statistically significant rapid reduction of depressive symptoms in patients with major depressive disorder who have current suicidal ...
Janssen Announces U.S. FDA Approval of SPRAVATO® (esketamine) CIII Nasal Spray to Treat Depressive Symptoms in Adults with Major Depressive Disorder with Acute Suicidal Ideation or Behavior
Aug 03, 2020 United States- SPRAVATO® is the first and only approved antidepressant medication shown to begin improving depressive symptoms with the first dose in this challenging to treat patient population- Approval is based on Phase 3 data showing ...