Johnson & Johnson filed an application seeking U.S. approval for its antidepressant nasal spray esketamine.
The company filed a new drug application with the U.S. Food and Drug Administration to market the product. A similar filing is planned by the company with the European Medicines Agency.
The application is supported by the results of five late-stage studies, including those in which the drug delayed depression relapse and reduced depression symptoms. In the U.S., the medicine was granted the breakthrough therapy status.
The therapy is aimed at adults who have not responded to two or more available antidepressants in a current episode of depression. Of the nearly 300 million people who suffer from major depressive disorder worldwide, about one-third do not respond to available treatments, according to Johnson & Johnson.
The esketamine nasal spray is also being studied as a treatment of major depressive disorder with imminent risk for suicide.