Janssen Pharmaceutical Companies has announced that both the ASPIRE I & ASPIRE II Phase 3 clinical studies of esketamine nasal spray in addition to standard of care (SOC) for the treatment of major depressive disorder in adult patients with active suicidal ideation with intent have met their primary endpoints. In both studies, the nasal spray plus SOC demonstrated statistically significant and clinically meaningful superiority compared to placebo plus standard of care in reduction of depressive symptoms 24 hours following the initial dose.
The trials enrolled 456 patients with moderate-to-severe major depressive disorder of whom 85 percent were considered to be moderately to extremely suicidal. All of the patients were hospitalized and given antidepressant medication. According to Janssen, the superior reduction in depressive symptoms for esketamine plus SOC was measurable four hours after the initial dose and was maintained over 25 days as both the esketamine and placebo groups showed improvement.
Regarding the newly published data, Janssen Research & Development Senior Director of Clinical Research Carla Canuso said, “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. 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.”
Janssen Research & Development Global Head, Neuroscience Therapeutic Area, Husseini K. Manji commented, “These are the first global clinical studies in this severely ill patient population, who are typically excluded from antidepressant treatment studies. At Janssen, we are committed to continued clinical research excellence that leads to discovery and development of new and more effective treatment options for people living with mental illnesses, including severe mood disorders. The esketamine nasal spray development program is a demonstration of that commitment and our recognition of the great unmet need among individuals with major depressive disorder who experience suffering from a serious, biologically based disease which has a significant negative impact on various aspects of life.”
Janssen’s Spravato esketamine nasal spray was approved by the FDA for for the treatment of treatment-resistant depression in March 2019. The company also submitted an MAA to the EMA in October 2018 shortly after announcing that a Phase 3 trial of the nasal spray had failed to meet its primary endpoint. Janssen had announced mostly positive results from two Phase 3 studies in May 2018.
Read the Janssen press release.
