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The emerging treatment of clinical depression has reached an important milestone. This week, the Food and Drug Administration approved Johnson & Johnson’s ketamine-based nasal spray, Spravato, as the only treatment for depression that has not responded to other treatments.
J&J he announced additional approval by the FDA on Tuesday. In the past, Spravato was approved as an adjunctive treatment for treatment-resistant depression, in combination with an oral antidepressant. The increased use indicates a promising future for ketamine and similar drugs as medical treatments.
You were fine first approval and the FDA in 2019, following years of research showing that ketamine treatment can provide unique and immediate benefits. Although ketamine is perhaps best known as a recreational drug with dissociative effects, it has also been used as a pain reliever. Prior to Spravato’s approval, intravenous ketamine was a widely used, if under-labeled, treatment for severe depression. However, Spravato contains a different type of ketamine than the one used intravenously—a drug called esketamine.
In the years since its approval, Spravato and ketamine have continued to demonstrate their potential as treatments for depression. Research following its release has found, for example, that ketamine he can winner other treatments for treatment-resistant depression, such as certain antidepressants. The FDA granted additional approval for Spravato on the basis of 4 additional clinical trials, which compared Spravato alone with placebo.
A double-blind, randomized, and controlled trial with drug-resistant patients, who were assigned to three groups: two groups that received different forms of Spravato twice a week for four weeks and a control group that received a placebo. Those on Spravato experienced significant and sustained reductions in depression symptoms compared to controls, the study found. Only 7.6% of patients who took a placebo achieved remission of their symptoms, for example, compared to 22.5% of people who took Spravato. The drug also appeared to be as safe as it appeared in previous trials.
“Treatment-resistant depression can be difficult, especially for patients who do not respond to or tolerate antidepressants,” said Bill Martin, global head of neuroscience at J&J’s innovative medicine division. words. “Spravato is now available as a stand-alone treatment, meaning patients can see improvement in depression symptoms as early as 24 hours and 28 days—without the need for daily oral antidepressants.”
Like any drug, ketamine is not without its risks. When used for depression, common side effects may include sedation, dissociation, and dyspnea (slow or shallow breathing). These side effects and the risk of harmful dependence have led the FDA to issue a special treatment plan for Spravato patients, known as the Risk Evaluation and Mitigation Strategy, or REMS, program. People who take Spravato can do so in hospitals or medical offices that are licensed to dispense it, and under medical supervision.
However, the development of Spravato as a stand-alone treatment means that more people with allergic reactions will have access to the drug. Over time, one of the main reasons why researchers have been so interested in ketamine is that it is a drug goals Different receptors in the brain are tied to depression than other drugs. This not only allows ketamine to help people who have not responded to previous treatment, one day it may mean the arrival of new medicine which work in the same way. And if these drugs can be made safe, then they can also be a precursor to depression.
