Janssen Pharmaceutical has reported positive outcomes from two long-term Phase III clinical trials of its drug candidate esketamine nasal spray in patients suffering from treatment-resistant depression.
Esketamine is an investigational, glutamate receptor modulator that is believed to restore synaptic connections in brain cells of people with major depressive disorder.
In the first trial, treatment using esketamine and an oral antidepressant beyond 16 weeks of therapy had a clinically meaningful and statistically significant superiority in delaying the time to relapse of depression symptoms.
This combination was compared to oral antidepressant and placebo nasal spray combination in adults with treatment-resistant depression.
It was found that patients administered with the esketamine combination experienced a 51% lower risk of relapse. The combination also demonstrated overall safety and tolerability with long-term usage.
During the second open-label study, esketamine nasal spray and oral antidepressant therapy was observed to be related to sustained improvement in depressive symptoms up to 52 weeks.
The esketamine combination demonstrated favourable tolerability and safety profile without any new safety signals even after repeated long-term dosing.
This is said to be the first trial to investigate the long-term safety and efficacy of esketamine nasal spray for up to one year.
Janssen Research & Development global head Mathai Mammen said: “We are pleased to share these results from our Phase III programme for esketamine nasal spray. They reinforce its potential to help patients who haven’t responded to available therapies.
“We look forward to submitting all results from our esketamine treatment-resistant depression studies to regulatory authorities, with a view to bringing a new treatment option to people in need.”
Esketamine nasal spray has been studied in a total of five pivotal Phase III trials for treatment-resistant depression, and if approved would be one of the first new approaches available for treating refractory major depressive disorder in the past 50 years.