The recent FDA approval of the use of esketamine for treatment-resistant depression means many Americans suffering will soon find relief. The drug, Spravato, was approved for patients who have failed to respond at all to at least two other antidepressant medications. After years of clinical trials, the decision to officially approve Spravato took a month before a panel of experts voted in favor of the new treatment. Since treatment-resistant depression plagues so many among us, this new treatment has generated tremendous hope for depression sufferers, their loved ones, and their mental health clinicians.
Since it was developed in 2016, we’ve blogged several times about esketamine—the isomer of ketamine being developed by Janssen Pharmaceuticals, designed to rapidly alleviate the symptoms of treatment-resistant depression. Esketamine, which will be administered intranasally, was granted breakthrough medication status by the FDA and fast-tracked for approval. And the time for approval is here.
In August 2016, Janssen Research & Development—a Janssen Pharmaceutical Company of Johnson & Johnson—announced that an isomer of ketamine, called esketamine, had received Breakthrough Therapy Designation by the Food & Drug Administration (FDA). Similarly to ketamine, esketamine has shown huge promise as a depression treatment, especially for those experiencing suicidal ideation, or who have resisted other treatment methodologies.