FDA Approves First Major Depression Drug in Over 30 Years
The FDA approves Johnson & Johnson's Spravato, an esketamine nasal spray for treatment-resistant depression. The fast-acting medication brings the first major breakthrough in depression treatment since the introduction of Prozac.
The U.S. Food and Drug Administration approves a new esketamine nasal spray called Spravato, marking the first major depression treatment breakthrough in over three decades. Manufactured by Johnson & Johnson, this fast-acting medication targets patients who do not respond to traditional antidepressants and works much more rapidly than current options on the market.
Due to safety concerns such as sedation, dissociation, and potential for misuse, the FDA requires Spravato to be distributed through a strict Risk Evaluation and Mitigation Strategies program. Patients administer the nasal spray themselves but must do so strictly inside a certified doctor's office or clinic, meaning they cannot take the medication home.
Clinical trials show mixed but promising results for the treatment. One short-term study demonstrates a statistically significant effect compared to a placebo, with some patients experiencing improvements within just two days, while a longer-term trial shows the medication delays relapse effectively.