FDA approves Johnson & Johnson’s nasal spray for depression as stand-alone treatment

Key Points

  • Spravato, Johnson & Johnson's nasal spray, has been approved by the FDA for use alone in treating treatment-resistant depression in adults.
  • The drug has shown significant sales growth, with expectations to reach between $1 billion and $5 billion annually.

Summary

The FDA has approved Johnson & Johnson's Spravato nasal spray for standalone use in treating adults with treatment-resistant major depressive disorder. This approval marks Spravato as the first therapy of its kind for this condition, where standard treatments fail to alleviate symptoms. Previously, Spravato was used in conjunction with oral antidepressants for similar conditions and for patients with suicidal thoughts. The drug, which entered the U.S. market in 2019, has shown promising results in clinical trials, demonstrating both rapid and durable symptom relief when used alone. Despite its potential, Spravato's administration is restricted due to risks like sedation and dissociation, requiring it to be given under strict medical supervision. The approval comes at a time when J&J is looking to bolster its portfolio amidst upcoming patent expirations and price negotiations, with Spravato's sales already reaching $780 million in the first nine months of 2024. The drug's growth is supported by its unique mechanism of action, offering quicker relief compared to traditional antidepressants, and its increasing acceptance among healthcare providers as they become more familiar with its benefits and administration protocols.

cnbc
January 21, 2025
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