SPRAVATO ® (Esketamine Nasal Spray) Authorised in Europe for the Rapid Reduction of Depressive Symptoms in a Psychiatric Emergency for Patients with Major Depressive Disorder

BEERSE, BELGIUM, February 8, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has authorised the expanded use of SPRAVATO® (esketamine nasal spray), co-administered with oral antidepressant therapy in adults with a moderate to severe episode of MDD, as acute short term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency.7 “Depression is more than just feeling sad, it’s a debilitating combination of symptoms that are different for each person and can progress to a point where patients may experience a psychiatric emergency,” said Professor Maurizio Pompili†, Director, University Psychiatric Clinic, Sant'Andrea Hospital, Sapienza University of Rome, Italy. “Many antidepressants are effective in treating depressive symptomatology but do not provide rapid relief for patients and can take weeks to achieve their full effect. The fast-acting nature of esketamine nasal spray in these patients may address a key unmet need within this population.” The EC authorisation of esketamine nasal spray is based on data from the Phase 3 double-blind, randomised, placebo controlled, multicentre ASPIRE I & II clinical studies conducted globally. These studies compared the efficacy and safety of esketamine nasal spray in combination with comprehensive standard of care (SOC) against placebo nasal spray in combination with comprehens...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news