The Food and Drug Administration (FDA) has approved Spravato, Johnson & Johnson’s nasal spray treatment, as a standalone therapy for treatment-resistant depression (TRD). This marks a significant breakthrough, as Spravato becomes the first medication approved as a sole treatment for individuals whose depression does not respond to traditional therapies.
Previously, Spravato was only authorized for use alongside oral antidepressants, targeting patients with TRD or those experiencing suicidal thoughts. Now, patients have the flexibility to use Spravato on its own, particularly if traditional antidepressants have proven ineffective or caused unwanted side effects such as weight gain or sexual dysfunction.
Depression affects over 21 million adults in the United States, with one-third of those patients struggling with treatment-resistant symptoms such as persistent sadness, sleep disturbances, fatigue, and suicidal thoughts. The approval of Spravato as a standalone option offers new hope for these individuals.
Dr. Gregory Mattingly, a physician and clinical researcher, emphasized the impact of this development, noting that Spravato delivers rapid symptom relief, with some patients experiencing improvement within 24 hours. Unlike traditional antidepressants, which can take weeks to months to show results, Spravato works quickly by activating neural networks in a unique way.
The drug’s success is reflected in its growing use. More than 6,000 patients have received Spravato at Mattingly’s St. Louis treatment center, one of 3,000 certified outpatient clinics in the U.S. that administer the medication under strict supervision.
Johnson & Johnson reported that Spravato generated $780 million in revenue in the first nine months of 2024, with sales expected to surpass $1 billion annually. The company sees Spravato’s growth as essential, especially as it faces patent expirations and pricing negotiations for other key drugs.
Despite its benefits, Spravato requires careful monitoring due to potential side effects, including sedation, dissociation, and risk of misuse. It is only available in certified healthcare settings, where patients must be monitored for two hours post-administration.
After a slow start following its 2019 launch, Spravato has gained widespread acceptance among healthcare providers, thanks to real-world data and studies demonstrating its superior efficacy compared to oral antidepressants. This approval marks a pivotal moment in mental health treatment, offering new possibilities for patients with severe depression.
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