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.
She continued, “Although currently available antidepressants are effective for many patients, their onset of effect can take four to six weeks, offering limited benefit to those in urgent need.”
The 456 patients who participated in the trials had moderate-to-severe major depressive disorder. More than 85 percent were rated by clinicians to be moderately to extremely suicidal.
Janssen submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for the Spravato treatment-resistant depression indication in Europe in October 2018.