Regulatory & Safety

Esketamine nasal spray for ‘debilitating mental illness’ recommended for approval

The committee reached this conclusion after analyzing the safety and efficacy data from five Phase III studies​ conducted in patients with treatment-resistant depression. Data from the studies demonstrated that intranasally delivered esketamine, alongside an oral antidepressant, provided statistically significant, rapid, and sustained improvement of depressive symptoms. Spravato (esketamine) nasal spray Czytaj więcej…