The FDA has approved Spravato (esketamine) nasal spray for use as monotherapy for patients with treatment-resistant depression.
CIII nasal spray, marking the first monotherapy to be approved for adults with treatment-resistant depression (TRD).
Following U.S. FDA Priority Review, approval is based on data demonstrating SPRAVATO® alone met its primary endpoint at 4 weeks and led to rapid and superior improvement in depressive symptoms ...