New Nasal Treatment Gains FDA Approval for Hard-to-Treat Depression

FDA website on a computer screen.

FDA approves ketamine-derived nasal spray for severe depression, raising concerns about potential abuse and misuse.

Key Takeaways

  • Johnson & Johnson’s Spravato nasal spray receives FDA approval for standalone treatment of severe depression
  • Spravato can potentially improve depression symptoms within 24 hours
  • The drug is derived from ketamine, a Schedule III controlled substance with a history of recreational abuse
  • Due to risks, Spravato is only available through a restricted program with strict administration guidelines
  • Approval offers new hope for millions suffering from treatment-resistant depression in the U.S.

Breakthrough Treatment for Severe Depression

The FDA’s approval of Johnson & Johnson’s Spravato nasal spray as a standalone treatment for severe depression marks a significant milestone in mental health care. This ketamine-derived medication offers new hope for the millions of Americans suffering from treatment-resistant depression. Approximately 21 million adults in the U.S. struggle with major depressive disorder, with one-third not responding to traditional antidepressant treatments.

Spravato, initially approved in 2019 for use in combination with antidepressants, has now been given the green light for standalone use. This development targets adults who have shown poor responses to traditional antidepressants, potentially improving depression symptoms within 24 hours. The rapid onset of relief could be a game-changer for those suffering from severe, debilitating depression.

Rigorous Approval Process and Potential Risks

The FDA’s decision was based on a rigorous, randomized, double-blind, multicenter, placebo-controlled study that demonstrated rapid symptom improvement. However, the approval comes with strict guidelines due to the potential risks associated with the drug. Spravato, derived from esketamine, a component of the anesthetic ketamine, is more potent than its parent compound, allowing for lower doses and potentially fewer side effects.

“Because it’s more potent, you can use it at a lower dose and theoretically have fewer side effects,” Kaplin said in a statement.

Despite its potential benefits, Spravato carries risks of abuse, sedation, dissociation, and respiratory depression. To mitigate these risks, the FDA has mandated that Spravato be available only through a restricted program called the Risk Evaluation and Mitigation Strategy. This ensures that the drug is administered under direct supervision of a healthcare provider in certified treatment centers.

Economic Impact and Future Prospects

The approval of Spravato as a standalone treatment could have significant economic implications. In the first nine months of 2024, Spravato generated approximately $780 million in sales for Johnson & Johnson. This figure is likely to increase with the expanded approval, potentially making Spravato a blockbuster drug in the psychiatric medication market.

“Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them,” said Bill Martin with the company’s innovative medicine department. “For too long, healthcare providers have had few options to offer patients much-needed symptom improvement.” – Source

While the approval of Spravato offers new hope for those suffering from treatment-resistant depression, it’s crucial to remain vigilant about potential misuse. The FDA issued a compounding risk alert in February 2022 regarding ketamine-based nasal sprays for psychiatric disorders, highlighting the need for continued monitoring and responsible use of this powerful medication.

Sources:

  1. FDA Approves Ketamine-Derived Nasal Spray to Treat Severe Depression
  2. FDA allows standalone use of nasal spray antidepressant Spravato (esketamine)