Europe – Spravato reduces depressive symptoms in 24 hours

Janssen has announced data from two pivotal Phase III clinical studies showing that the nasal spray Spravato (esketamine) caused a reduction in depressive symptoms at 24 hours after the first dose, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS).

The trial evaluated the efficacy and safety of the drug in addition to comprehensive standard of care (SOC) in adult patients with major depressive disorder who have active suicidal ideation with intent, and in both studies showed clinically meaningful and statistically significant superiority over placebo in rapidly reducing symptoms of major depressive disorder.

The safety profile observed was also consistent across the two studies, with  the most common adverse events being dizziness, dissociation, nausea, somnolence, vision blurred, vomiting, paresthesia, increased blood pressure and sedation.

“These data are particularly important because patients with major depressive disorder presenting with active suicidal ideation with intent constitute a psychiatric emergency that requires immediate intervention,” said Carla Canuso, senior director, clinical research, Janssen Research & Development…