FDA approval announcements or Johnson & Johnson press releases

FDA Approves J&J's Nasal Spray Spravato for Treatment-Resistant Depression

Jan 21, 2025, 07:16 PM

The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson's nasal spray, Spravato, as the first-ever standalone treatment for adults with treatment-resistant major depressive disorder (MDD). Previously approved in 2019 for use alongside oral antidepressants, Spravato's new designation allows it to be used independently. The drug, derived from esketamine, is intended for patients who have not responded to at least two oral antidepressants. Clinical trials demonstrated that Spravato can improve depressive symptoms within 24 hours, with effects lasting up to a month. The approval, granted following FDA priority review, follows over a decade of research and six years of real-world data, during which the drug has been administered to more than 140,000 patients globally. Spravato generated $780 million in sales during the first nine months of 2024 and is projected to become a blockbuster product, with annual sales expected to reach between $1 billion and $5 billion. The treatment, administered under a restricted program in certified healthcare settings, requires patients to be monitored for two hours due to potential side effects, including the risk of misuse. This approval is seen as a significant advancement for patients with limited options for managing treatment-resistant depression.