The Food and Drug Administration (FDA) has approved a new form of treatment for treatment-resistant depressionwhich could represent a key alternative for many patients who do not respond to conventional treatments.
This is Spravato, a nasal spray developed by Johnson & Johnson, which can be used independently, without the need to be accompanied by an oral antidepressant. This advance promises to transform the lives of the millions of people who suffer from major depressive disorders and who cannot improve with standard treatments.
Spravato was initially approved in 2019 as an adjunct to oral antidepressants, but with this new approval, it can now be used as a single therapy for those patients with treatment-resistant depression.
This condition affects one-third of the approximately 21 million adults in the United States who suffer from major depression, who show no improvement despite trying at least two different antidepressant treatments.
Bill Martin, head of global neuroscience at Johnson & Johnson, highlighted the importance of this medication, highlighting that untreated depression can be fatal, especially when patients experience suicidal thoughts.
According to estimates, Major depression can include symptoms such as persistent sadness, fatigue, sleep disorders, and self-destructive thoughts. which puts patients at high risk of harm or death if not treated appropriately.
Spravato, whose active ingredient is ketamine, has been shown to be effective in inducing relief from depressive symptoms in the short term. In clinical studies, patients began to experience improvements in their emotional state just 24 hours after treatment, and the beneficial effects continued for at least a month.
This speed is a fundamental difference compared to traditional antidepressants, which can take weeks or even months to take effect.
The spray should be administered under medical supervision
The nasal spray is administered in a clinical setting under close medical supervision due to the risks of serious side effects such as sedation, dissociation, respiratory depression, and suicidal thoughts.
Therefore, patients should remain under observation for at least two hours after administration.. This restrictive and supervised approach is essential to ensure patient safety while reaping the benefits of the medication.
Although the rollout of Spravato was slow, especially due to complications from the pandemic, doctors and mental health facilities have begun to embrace the use of the medication more frequently.
FDA approval as a stand-alone therapeutic option reinforces confidence in its effectiveness and safety. Results from a phase four trial confirmed that the drug has a safety profile consistent with previous data and provides both rapid and long-lasting relief.
Dr. Gregory Mattingly, president of the Midwest Research Group, who participated in the clinical trials, noted that patients now have the option of choosing whether to take Spravato along with an oral antidepressant or on its own. allowing them to avoid the undesirable side effects of oral medications, such as weight gain or sexual problems. The ability to personalize treatment is one of the great advantages of this approach.
In terms of economic impact, Spravato has been a success for Johnson & Johnson. During the first nine months of 2024, the drug generated sales of $780 million, and the company expects revenue to increase even further in the future, reaching between $1 billion and $5 billion annually.
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