FDA Approves First Nasal Spray for Treatment-Resistant Depression

On Tuesday, January 21st, the U.S. Food and Drug Administration (FDA) approved Johnson & Johnson’s nasal spray, Spravato, as the first standalone treatment for individuals with treatment-resistant depression. This innovative medication, based on esketamine hydrochloride, a derivative of ketamine, offers a groundbreaking option for patients who have not responded to at least two conventional oral antidepressants.

Spravato was initially approved in May 2019 for use alongside oral antidepressants. However, the FDA’s latest decision allows it to be used independently, addressing a critical need for patients suffering from persistent depression symptoms such as prolonged sadness, low energy, sleep disturbances, and suicidal thoughts. According to Johnson & Johnson, this approval offers patients the flexibility to discontinue oral medications that may cause undesirable side effects, such as weight gain and sexual dysfunction.

The nasal spray demonstrates rapid results, with some patients reporting relief within 24 hours of the first dose. Dr. Gregory Mattingly, a physician involved in clinical trials, noted that Spravato’sunique mechanism allows for immediate activation of neural networks, a significant improvement over traditional antidepressants that may take weeks to show efficacy.

Despite its promise, the treatment is not without risks. Spravato can cause side effects, including dizziness, sedation, anxiety, and dissociation. To mitigate these concerns, the drug is administered exclusively in certified healthcare settings under the Spravato Risk Evaluation and Mitigation Strategy Program. Patients are monitored for at least two hours post-administration to ensure safety.

With an estimated one-third of the 21 million U.S. adults with major depression classified as treatment-resistant, the approval of Spravato is a significant milestone. Bill Martin, Johnson & Johnson’s neuroscience division head, emphasized that the drug’s approval paves the way for personalized treatment plans, potentially expanding its reach to more patients.

Spravato has already demonstrated commercial success, with 140,000 patients treated worldwide and $780 million in sales in 2024. Johnson & Johnson anticipates annual revenue from Spravatoto to reach between $1 billion and $5 billion, a good thing as the company faces upcoming patent expirations for other products.

This FDA approval marks a crucial advancement in addressing the unmet needs of individuals battling severe depression, providing hope and relief for many who have struggled without effective options.