Originally Published by Johnson & Johnson.
The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for esketamine nasal spray. Janssen is seeking FDA approval of esketamine for treatment-resistant depression in adults.
Esketamine is an investigational, rapidly acting antidepressant that works differently than currently available therapies for major depressive disorder. Through glutamate receptor modulation, esketamine is thought to help restore connections between brain cells in people with treatment-resistant depression.
“Of the nearly 300 million people who suffer from major depressive disorder worldwide, about one-third do not respond to currently available treatments. This represents a major unmet public health need,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. “We are committed to working with the FDA to bring this new treatment option to U.S. patients with treatment-resistant depression and to the medical community.”
The NDA is based on five pivotal Phase 3 studies of esketamine nasal spray in patients with treatment-resistant depression: three short-term studies, one withdrawal maintenance of effect study, and one long-term safety study. Data from these studies demonstrate that treatment with esketamine nasal spray plus a newly initiated oral antidepressant compared to placebo nasal spray plus a newly initiated antidepressant was associated with rapid reduction of depressive symptoms and delayed time to relapse of symptoms of depression. The long-term safety study showed that the esketamine doses studied were generally tolerated, with no new safety signals with dosing up to 52 weeks, compared to data from the short-term esketamine studies.7 The short-term esketamine Phase 3 study in adults with treatment-resistant depression included a newly initiated oral antidepressant in both the control and placebo groups.
“Esketamine has been shown to target critical aspects of glutamate-mediated synaptic plasticity, thereby bringing about rapid and sustained improvement in people with treatment-resistant depression,” said Husseini K. Manji, MD, Global Head, Neuroscience Therapeutic Area, Janssen Research & Development, LLC.
Synaptic plasticity refers to the strength of information that flows through synapses, the spaces where neurons, cells in the brain, are connected.
Esketamine nasal spray will be self-administered by patients under the supervision of health care professionals.
The U.S. FDA granted Breakthrough Therapy Designations for esketamine nasal spray for treatment-resistant depression and for a second indication, major depressive disorder with imminent risk for suicide.8 Janssen is currently conducting Phase 3 clinical studies for the second indication.
Janssen plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the esketamine treatment-resistant depression indication later in 2018.
More information on the esketamine Phase 3 study results can be accessed via the following links:
