Ketamine Nasal Spray is approved as a stand-alone treatment for severe depression

An emerging treatment for clinical depression has reached a milestone. This week, the Food and Drug Administration approved Johnson & Johnson’s ketamine-based nasal spray, Spravato, as a stand-alone treatment for depression that doesn’t respond to other options.

J&J announced Further FDA approval on Tuesday. Previously, Spravato was approved as adjunctive therapy for treatment-resistant depression in combination with an oral antidepressant. Widespread use signals a promising future for ketamine and similar drugs as mental health interventions.

You were good first approval Following studies by the FDA in 2019, suggesting that ketamine therapy may provide unique and fast-acting antidepressant benefits. Although ketamine is perhaps more popular as a recreational drug with dissociative effects, it has long been used medically as an anesthetic. Before Spravato’s approval, intravenous ketamine became a growing, if off-label, option for difficult depression. However, Spravato contains a different form of ketamine than that used intravenously—a chemical sibling called esketamine.

After approval, Spravato and ketamine continued to show potential as depression treatments. After its release, studies found, for example, ketamine can exceeds other standard alternatives for treatment-resistant depression, such as certain antipsychotics. The FDA granted Spravato’s expanded approval based on another post-market phase 4 trial, one of which compared Spravato with placebo alone.

The double-blind, randomized, controlled trial involved people with treatment-resistant depression who were assigned to 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 those on Spravato experienced significant and sustained reductions in depressive symptoms compared to controls. For example, only 7.6% of patients taking placebo experienced a clear remission of their symptoms, compared with 22.5% of those taking Spravato. The drug was also as safe as it appeared 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, head of global therapeutics for neuroscience in J&J’s innovative medicine department. statement. “Spravato is now available as a stand-alone treatment, meaning patients can experience improvement in depressive symptoms within 24 hours and 28 days without the need for daily oral antidepressants.”

Like any drug, ketamine is not without risks. When used for depression, common side effects can include sedation, dissociation, and respiratory depression (extremely slow or shallow breathing). These side effects and the potential risk of harmful addiction have led the FDA to require a specific treatment strategy for providing patients with Spravato, known as the Risk Evaluation and Mitigation Strategy, or REMS program. People taking Spravato can only do so in clinics or medical facilities certified to dispense it and only under the direct supervision of a doctor.

Still, Spravato’s expansion into stand-alone therapy means more people with treatment-resistant depression will be able to turn to the drug. In the long run, a big reason why researchers are so excited about ketamine is the drug goals Different receptors in the brain are linked to depression compared to other drugs. Not only does this allow ketamine to help people who have not responded to past treatments, but it could mean that one day it will. newer drugs works similarly. And if these drugs can be made safer, then they could become frontline treatments for depression in general.