Johnson & Johnson subsidiary Janssen Pharmaceutical has submitted an NDA for esketamine nasal spray for the treatment of treatment-resistant depression in adults, the company said. Janssen said that it plans to submit an MAA to the EMA for esketamine nasal spray for the same indication later this year.
In May 2018, Janssen published positive results from a Phase 3 study of the esketamine nasal spray. According to the company, the NDA is supported by data from 5 Phase 3 studies in treatment-resistant depression patients, including 3 short-term studies, a withdrawal study, and a long-term safety study.
The esketamine nasal spray has received Breakthrough Therapy designation for this indication and for major depressive disorder with imminent risk for suicide.
Janssen Research & Development Global Head Mathai Mammen commented, “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. 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.”
Read the Janssen Pharmaceutical press release.
