FDA Approves Ketamine-Like Drug for Severe Depression

FDA Approves Ketamine Nasal Spray For Depression

FDA Approves Ketamine Nasal Spray For Depression

Johnson & Johnson has stated that the name brand of esketamine, which will be administered via nasal spray, will be Spravato.

The U.S. Food and Drug Administration on Tuesday approved the nasal spray medication esketamine - a relative of the club drug and anesthetic ketamine - for use against severe depression.

"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition", said Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research.

Nevertheless, many hope that this new treatment will be a step in the right direction for mental health in the United States. According to the expert and as reported by Rolling Stone, The approval has been granted by the agency after several successful clinical trials on the effectiveness and safety of the drug, and also after it passed their careful review.

Treatment-resistant depression is classified as major depressive disorder that has not responded to at least two different antidepressants at adequate doses during a depressive episode.

However, the USA multinational pharmaceutical conglomerate had also placed restrictions over the use of the drug, saying that it could widely by abused and misused. During and after each use of the device, the health care provider will check the patient and determine when the patient is ready to leave. After continuing Spravato as a treatment and were shown to be 51% less likely to relapse compared patients given a placebo and oral antidepressant.

One of the best things about esketamine is that patients see results many times more quickly than in traditional antidepressants like SSRIs, or selective serotonin reuptake inhibitors, which take weeks, if not months, to begin working.

The most common side effects of Spravato include sedation, disassociation, dizziness, nausea, vertigo, lethargy, hypoesthesia or decreased sensitivity, anxiety, increased blood pressure, as well as vomiting.

The FDA granted the approval of Spravato to Janssen Pharmaceuticals, Inc.