The New Drug Application (NDA) for esketamine nasal spray for use in patients with treatment-resistant depression has been submitted to the Food and Drug Administration (FDA).
Esketamine is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. The NDA includes five Phase 3 studies in patients with treatment-resistant depression: 3 short-term studies, 1 withdrawal maintenance of effect study, and 1 long-term safety study. Results from these studies showed that treatment with esketamine nasal spray plus a newly initiated oral antidepressant was associated with a clinically meaningful rapid reduction of depressive symptoms vs placebo nasal spray plus a newly initiated oral antidepressant.
In the long-term study, the most common treatment-emergent adverse events (≥10% of patients) were dizziness (32.9%), dissociation (27.4%), nausea (25.1%), headache (24.9%), drowsiness (16.7%), metallic taste or oral hypoaesthesia (11.8% each), vertigo (11.0%), vomiting (10.8%), and viral upper respiratory tract infection (10.2%). Esketamine was generally tolerated, with no new safety signals with dosing up to 52 weeks, compared to data from the short-term esketamine studies.
Esketamine spray is intended to be self-administered by the patient. “We are committed to working with the FDA to bring this new treatment option to US patients with treatment-resistant depression and to the medical community,” said Mathai Mammen, MD, PhD, Global Head, Janssen Research & Development.
For more information visit Janssen.com.