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. There are 3,000 certified outpatient treatment centers in the U.S. authorized to administer Spravato.
The recent approval allows for personalized treatment approaches, offering patients the choice to use Spravato with or without an oral antidepressant, especially if the latter is ineffective or causes undesirable side effects. J&J anticipates an increase in the number of patients benefiting from Spravato, potentially making it a blockbuster product.
The approval was based on a phase four trial demonstrating Spravato’s efficacy in improving depressive symptoms within 24 hours of treatment, lasting for at least one month. The drug’s safety profile was consistent with previous data when used in combination with oral antidepressants.
Spravato, related to ketamine, acts quickly by turning on neural networks in the brain. It differs from standard oral antidepressants, which may take weeks to months to show effects. The drug’s warning label highlights potential side effects such as sedation, dissociation, respiratory depression, suicidal thoughts, and abuse or misuse.
Due to these risks, Spravato is only available through a restricted program in certified healthcare settings under strict supervision. Users must be monitored for two hours post-administration. Despite a slow start, the drug’s adoption increased as physicians became more familiar with its benefits and procedures for its use.
Real-world data and studies demonstrating Spravato’s efficacy compared to oral antidepressants have boosted confidence among healthcare providers. If experiencing suicidal thoughts or distress, individuals are encouraged to contact the Suicide & Crisis Lifeline at 988 for support from trained counselors.
