Johnson & Johnson subsidiary Janssen has announced its esketamine nasal spray reduced depressive symptoms in adult major depressive disorder patients with suicidal ideation with intent when combined with the standard of care.
Reducing depressive symptoms 24 hours after the first dose of esketamine was the primary endpoint of two Phase III trials, Aspire I and II, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS).
Compared to hospitalisation and newly initiated or optimised antidepressant therapy, the standard of care, plus placebo, esketamine reduced symptoms by 3.8 points on the MADRS scale in Aspire I and 3.9 in Aspire II.
The benefit of Janssen’s nasal spray was observed from four hours after the first dose and the clinical meaningful improvement continued until 25 days, the end of the studies’ double-blind period, as well as during the nine-week follow-up period.
Furthermore, 54% of the esketamine group in Aspire I and 47% in Aspire II achieved clinical remission at 25 days.
The secondary endpoint of the two Aspire trials was improvement in severity of suicidality at 24 hours following the first dose. Both the drug and placebo arm of the trial saw improvement in this endpoint, but the difference between the two was not statistically significant. Janssen concluded this may suggest the effectiveness of comprehensive standard of care in controlling suicidality severity.
The results were presented at the European College of Neuropsychopharmacology conference in Copenhagen, Denmark.
Janssen research and development senior director of clinical research and clinical leader of Aspire I and II 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 and development global head of neuroscience Husseini K. Manji said: “These are the first global clinical studies in this severely ill patient population, who are typically excluded from antidepressant treatment studies.
“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.”
Esketamine nasal spray is already US Food and Drug Administration approved in combination with newly initiated antidepressants for patients with treatment-resistant depression. The safety of esketamine in the Aspire I and II study was consistent with previous studies in the treatment-resistant depression population.