Results from two Phase III trials into nasal spray treatment of depression to be presented at event

The Janssen Pharmaceutical Companies of Johnson & Johnson, have announced the positive results from two Phase III clinical studies of esketamine nasal spray for the treatment of patients with treatment-resistant depression.

These data, which will be presented at the American Psychiatric Association Annual Meeting in New York, show that in adults with treatment-resistant depression, flexibly dosed esketamine nasal spray (with a newly initiated oral antidepressant) demonstrated a statistically significant reduction in symptoms compared with placebo nasal spray.

Esketamine nasal spray is an investigational compound being studied by Janssen Research & Development as part of a global development programme. It is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist, which is thought to help restore synaptic connections in brain cells in people with major depressive disorder — this is a novel mechanism of action.

“With about 30% of patients with major depression failing to respond to currently available antidepressants, treatment-resistant depression represents a major public health need,” said Dr Husseini K. Manji, global head, Neuroscience Therapeutic Area, Janssen Research & Development. “The positive Phase III results for esketamine nasal spray in adults with treatment-resistant depression are exciting, particularly as they mark the first time an antidepressant has achieved superiority versus an active comparator in any clinical trial for major depressive disorder. What makes this significant is that the response was rapid and this milestone was achieved in patients deemed to be treatment-resistant. We are also pleased with the clinically meaningful outcomes for esketamine nasal spray in elderly patients, a population that often has greater disability and lower response rates.”

“There’s a critical need for new, rapidly acting and effective treatment options for people with major depressive disorder who do not respond to existing therapies,” added Dr Mathai Mammen, PhD, global head, Janssen Research & Development. “Janssen is fully committed to exploring the newest science in the area of mood disorders and bringing these discoveries to patients in need.”

Esketamine has already received two breakthrough therapy designations from the US Food and Drug Administration (FDA) in 2013 for treatment-resistant depression and in 2016 for major depressive disorder with imminent risk for suicide. If it receives approval it will be one of the first new approaches in the treatment of refractory major depressive disorder available to patients within the past 50 years.