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The U.S. Food and Drug Administration on Tuesday said it approved Johnson & Johnson's nasal spray antidepressant that is chemically similar to often-abused ketamine, marking the first advance in treating depression in more than 30 years.
The treatment comes with a boxed warning — FDA's harshest — flagging the risk for sedation and difficulty with attention, judgment and thinking, abuse and misuse, and suicidal thoughts after administration of the drug.
Spravato nasal spray will be used along with a newly prescribed oral antidepressant, under supervision of health care professionals, the agency said.
Citing the risk of serious adverse outcomes and the potential for abuse and misuse, the FDA said the drug will be available through a restricted distribution system.
Spravato is a chemical mirror image of anesthetic ketamine, which is abused as a recreational party drug that goes by the street name Special K.
The decision comes after an FDA advisory panel recommended approval of the drug, Spravato, which is designed to treat depression in patients who have not benefited from two or more antidepressants.
"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," said Tiffany Farchione of the FDA's Center for Drug Evaluation and Research.
Spravato has been touted as an asset with blockbuster potential and is expected to improve investor sentiment toward the growth prospects of J&J's pharma unit Janssen, as its top-selling rheumatoid arthritis drug Remicade faces increased competition from cheaper biosimilars.
The drug is also being tested in patients with depression who are at a high risk of committing suicide.