In this article, the Food and Drug Administration has approved Johnson & Johnson’s nasal spray, Spravato, for use alone in adults with treatment-resistant major depressive disorder. This approval marks the first stand-alone therapy for this condition, where standard treatments have been ineffective in improving symptoms. Initially, Spravato was approved for use in combination with an oral antidepressant for treatment-resistant depression and for individuals with major depressive disorder experiencing suicidal thoughts.
Bill Martin, J&J’s global therapeutic area head of neuroscience, emphasized the importance of treating depression, highlighting its potentially fatal consequences if left untreated. Approximately one-third of the estimated 21 million U.S. adults with major depression do not respond to standard treatments, experiencing symptoms such as persistent sadness, sleep disturbances, low energy, and suicidal thoughts.
Dr. Gregory Mattingly, a physician involved in Spravato’s clinical trials, noted the significance of having a treatment option that provides patients with more freedom. The drug has been administered to over 6,000 patients at Mattingly’s center in St. Louis, with around 100 currently using it. Spravato is available in 3,000 certified outpatient treatment centers in the U.S.
The recent approval allows patients to choose whether to take Spravato with or without an oral antidepressant, especially if the latter is ineffective or causes undesirable side effects. J&J aims to personalize treatment options for individuals, potentially expanding the number of patients who could benefit from Spravato.
With sales of $780 million in the first nine months of 2024, Spravato is expected to become a blockbuster product. The drug’s approval was based on a phase four trial demonstrating rapid and durable symptom relief when used alone. Spravato, related to ketamine, acts quickly on neural networks, providing relief within a day of treatment.
Despite its benefits, Spravato carries risks such as sedation, respiratory depression, and suicidal thoughts, leading to its availability only through a restricted program in certified healthcare settings. The drug requires monitoring by a healthcare professional for two hours post-administration.
Following a slow start, Spravato’s market presence has increased as physicians became more familiar with its benefits. Real-world data and studies showing its efficacy compared to oral antidepressants have boosted confidence in the treatment. If experiencing suicidal thoughts or distress, individuals can seek support from the Suicide & Crisis Lifeline at 988.
