Emerging treatments for clinical depression have reached a milestone: This week, the Food and Drug Administration approved Johnson & Johnson's ketamine-containing nasal spray, named Spravato for use as a standalone treatment for cases of depression that have not responded to other options.
J&J Announced Additional FDA Approval Tuesday Spravato was previously approved as an add-on therapy for treatment-resistant depression. in combination with oral antidepressants This increased use signals a bright future for ketamine and similar drugs as a mental health intervention.
Spravato is first approval by the FDA in 2019, following research years later that suggested ketamine therapy could provide unique, fast-acting antidepressant benefits. Although ketamine may be notoriously known as a recreational drug with dissociative effects, But it has been used medically as an anesthetic for a long time. Prior to Spravato's approval, intravenous ketamine had become an increasing option. It can also be used (if not stated on the label) for difficult cases of depression. However, Spravato contains a different form of ketamine than the intravenous version. It is a chemical sibling called esketamine.
In the years since their approval, Spravato and ketamine have continued to show promise in treating depression. Post-launch studies have found that ketamine is can has superior efficiency Other standard options For treatment-resistant depression, such as certain antipsychotics, the FDA granted additional approval to Spravato on the basis of another post-marketing Phase 4 trial. This was a trial that compared Spravato alone with a placebo.
Double-blind, randomized, controlled trial involving people with treatment-resistant depression. This was divided into three groups: two groups received different doses of Spravato twice a week for four weeks; and a control group that received a placebo The study found that people who took Spravato had a significant and sustained reduction in depression symptoms when compared to a control group. Only 7.6% of placebo patients experienced significant improvement. This compared to 22.5% of those who received a placebo. The drug appears to be just as safe. with what appeared in previous experiments.
“Treatment-resistant depression can be very complicated. This is especially true for patients who do not respond to oral antidepressants or cannot tolerate them,” said Bill Martin, Global Head of Therapeutic Neurosciences. J&J's Innovative Medicine Division said in statement– “Spravato is now available as a standalone treatment. This means that patients may experience improvements in their depression symptoms from anywhere from 24 hours to 28 days, without the need to take daily oral antidepressants.”
Like other medicines Ketamine is not without risks. When used with depression Common side effects may include sedation. separation and respiratory depression (Breathing is too slow or too shallow.) These side effects and the potential risk of dangerous drug dependency have led the FDA to designate a special treatment strategy for giving Spravato to patients, known as an over-the-counter program. Risk Assessment and Mitigation, or REMS, people taking Spravato can take it at a clinic or medical office certified to sell it. and must be under direct medical supervision only
Still, Spravato's expansion into a standalone therapy could make the drug more accessible to people with treatment-resistant depression in the long term, one key reason researchers are excited about ketamine. There's a lot of it, it's the medicine. target Different receptors in the brain are linked to depression than other drugs. This not only allows ketamine to help people who have not responded to treatment in the past. But one day it may mean the arrival of never drugs that work in the same way And if these drugs can be made safer? Those drugs may also become the leading general treatment for depression.