Phase III clinical studies of Spravato meet endpoints in depression

The Janssen Pharmaceutical Companies of Johnson & Johnson announced positive results from two pivotal Phase III clinical studies (ASPIRE I & II) to evaluate the efficacy and safety of Spravato (esketamine) CIII nasal spray in addition to comprehensive standard of care (SOC) in adult patients with major depressive disorder who have active suicidal ideation with intent. The double-blind, randomized, placebo-controlled, multicenter studies both met their respective primary efficacy endpoint, which was a reduction in depressive symptoms at 24 hours after the first dose, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS).

In both studies, Spravato 84 mg plus SOC showed clinically meaningful and statistically significant superiority (p=0.006) over placebo plus SOC in rapidly reducing symptoms of major depressive disorder. In these studies, comprehensive SOC included initial hospitalization and newly initiated and/or optimized antidepressant therapy. In these studies, both Spravato plus comprehensive SOC and placebo plus comprehensive SOC resulted in improvement in severity of suicidality as measured by the revised Clinical Global Impression of Severity of Suicidality (CGI-SS-R) at 24 hours after the first dose. The treatment difference between the two groups on this secondary endpoint was not statistically significant. This may be due to the substantial beneficial effects of comprehensive SOC utilized in the clinical trial, including the impact of inpatient psychiatric hospitalization in diffusing the acute suicidal crisis in patients in both treatment groups.

In the ASPIRE I & II trials, Spravato plus SOC was well-tolerated with no new safety signals. These studies were presented at the 32nd European College of Neuropsychopharmacology (ECNP).