Nasal spray now approved as monotherapy for treatment-resistant depression
The FDA approved esketamine (Spravato) nasal spray as monotherapy for adults with treatment-resistant depression who had an inadequate response to at least two oral antidepressants, maker Johnson & Johnson announced on Tuesday. Used under the supervision of a healthcare provider, esketamine was first approved in 2019 for use alongside an oral antidepressant for treatment-resistant depression, and then received an additional indication in 2020 for adults with major depressive disorder plus acute suicidal ideation or behavior, in conjunction with an oral antidepressant. The drug acts as a non-selective, non-competitive antagonist of the NMDA receptor and works by targeting glutamate in the brain. While it is estimated that 21 million U.S. adults are living with major depressive disorder, roughly a third won't respond to oral antidepressants alone. "Patients often cycle through multiple oral medications, waiting 4-6 weeks for potential relief," said Johnson & Johnson in a statement. "After trying their third oral antidepressant, approximately 86% of patients do not achieve remission." In the 379-participant double-blind…