Ketamine nasal spray is approved as a stand-alone treatment for difficult cases of depression

Emerging treatment for clinical depression has reached an important milestone. The Food and Drug Administration this week approved Johnson & Johnson’s ketamine-based Spravato nasal spray as a stand-alone treatment for depression that hasn’t responded to other options.

Johnson & Johnson Announce The supplement was approved by the Food and Drug Administration on Tuesday. Previously, Spravato was approved as an add-on treatment for treatment-resistant depression, in combination with oral antidepressants. The expanded use indicates a promising future for ketamine and similar medications as mental health intervention.

It was Spravato It was approved for the first time By the US Food and Drug Administration in 2019, after years of research suggesting that ketamine treatment could provide unique, fast-acting antidepressant benefits. Although ketamine is perhaps poorly known as a recreational drug with dissociative effects, it has long been used medically as an anesthetic. Prior to Spravato’s approval, intravenous ketamine had become an increasing, albeit off-label, option for difficult cases of depression. However, Spravato contains a different form of ketamine than the intravenously used version — its chemical brother called esketamine.

In the years since its approval, Spravato and ketamine have continued to show potential as a treatment for depression. Studies following its release have found, for example, that ketamine He can excels Other standard alternatives for treatment-resistant depression, such as some antipsychotics. The FDA granted expanded approval for Spravato based on another post-marketing Phase 4 trial, one that compared Spravato alone to placebo.

The double-blind, randomized, controlled trial included people with treatment-resistant depression, divided into three groups: two groups that received different doses of Spravato twice a week for four weeks and a control group that received a placebo spray. The study found that people who took Spravato experienced a significant and sustained reduction in depression symptoms compared to the control group. For example, only 7.6% of patients who took placebo saw a significant reduction in their symptoms, compared to 22.5% of people who took Spravato. The drug also appears to be safe, as shown in previous trials.

“Treatment-resistant depression can be very complex, especially for patients who do not respond to or cannot tolerate oral antidepressants,” said Bill Martin, M.D., global therapeutic area chief for neuroscience in Johnson & Johnson’s Innovative Medicine Division. statement. “Spravato is now available as a stand-alone treatment, meaning patients may experience improvements in depression symptoms as early as 24 hours and as late as 28 days — without the need for daily oral antidepressants.”

Like any drug, ketamine is not without risks. When used to treat depression, common side effects can include sedation, dissociation, and respiratory depression (slow or very shallow breathing). These side effects and potential risks of adverse dependence led the FDA to mandate a special treatment strategy to provide Spravato to patients, known as a Risk Evaluation and Mitigation Program, or REMS program. People taking Spravato can only do so in clinics or medical offices approved to dispense it, and only under direct medical supervision.

However, Spravato’s expansion into standalone treatment means that more people with treatment-resistant depression will be able to access the medication. In the long term, one of the main reasons researchers are excited about ketamine is because it is a drug Objectives Different receptors in the brain are associated with depression compared to other medications. Not only does this allow ketamine to help people who have not responded to previous treatments, it may one day mean the arrival of… Newer drugs Which works in a similar way. If these drugs can be made safer, they could also become first-line treatments for depression in general.