FDA approves Johnson & Johnson's Fast-Acting Depression drug for quick relief from mental depression is undoubtedly a great success for the acute patients. He also is named as co-inventor on patents filed by the Icahn School of Medicine relating to the treatment for treatment-resistant depression, suicidal ideation and other disorders.
Esketamine is created to be administered intranasally twice a week for an initial 4 weeks, in conjunction with a newly initiated oral antidepressant.
In the case of esketamine (sold as Spravato), one of these concerns is that it's related to ketamine, which has been used as an anesthesia and to get high in the form of the once-popular party drug Special K. There's a concern that this new antidepressant may carry a risk of addiction and substance abuse.
The approval is in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them.
Esketamine has been advised to be used as a adjuvant along with other conventional antidepressants. It works nearly immediately. Ketamine was approved for use as an anesthetic in the 1970s.
Nevertheless, many hope that this new treatment will be a step in the right direction for mental health in the United States.
The FDA approval is a significant milestone not only for the company but for those living with MDD.
The FDA says the most common side effects of the drug observed in the trials included disassociation, dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity (hypoesthesia), anxiety, lethargy, increased blood pressure, vomiting and feeling drunk.
Spravato will cost between $590 and $885 per treatment. Even so, doctors can legally prescribe it for off-label medical uses. He's administered Ketamine treatments for the past eight years, taking in those who have failed with other antidepressants and are at risk for suicide. The FDA granted the drug both "Fast Track" and "Breakthrough Therapy" designations. Patients often pay hundreds or thousands of dollars for intravenous infusions of the drug over several weeks or months. However, he cautioned that we do not know much about the long-term impacts of the drug, telling the Washington Post: "Doctors will have to be very judicious and feel their way along". Out-of-pocket costs vary based on an individual's healthcare plans and the duration of treatment.