The U.S. Food and Drug Administration has broadened its approval of Johnson & Johnson's nasal spray, Spravato, permitting its use as a standalone treatment for individuals with severe depression, the company announced Tuesday.
Initially approved in 2019 for use alongside antidepressants, the ketamine-based medication was later authorized for treating patients with suicidal thoughts or behaviors
"Now that it is also available as a monotherapy, healthcare providers have the freedom to further personalize treatment plans based on individual needs," Gregory Mattingly, founding partner of St. Charles Psychiatric Associates, said in a statement.
Spravato, made from esketamine—one of two mirror-image molecules in the anesthetic ketamine—has received updated FDA approval, allowing it to be used independently of oral antidepressants.
Previously, patients taking Spravato were also required to use an oral antidepressant. This change follows a large study demonstrating that Spravato alone outperformed a placebo. In the first nine months of 2024, the medication generated approximately $780 million in sales for its manufacturer, Johnson & Johnson.
Administered under the direct supervision of a healthcare provider, Spravato targets severe cases of depression. An estimated one-third of the 21 million U.S. adults with major depression experience treatment-resistant symptoms, including persistent sadness, sleep issues, low energy, and suicidal thoughts.
"We want to recognize that this is a medicine that treats a disease that [when] left untreated, depression is potentially fatal," Bill Martin, J&J's global therapeutic area head of neuroscience, said in an interview, according to CNBC.
Martin described the FDA's expanded approval as an opportunity to "optimize and personalize the treatment paradigm for each individual." He emphasized that caregivers and patients can now determine the most effective approach to managing severe depression. This decision, Martin added, has the potential to "open up the number of patients who could benefit" from Spravato.
