March 5 (Reuters) - 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 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.
The health regulator said Spravato was approved for use in conjunction with an oral antidepressant. 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.
Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Cynthia Osterman