The Food and Drug Administration has approved a pioneering nasal spray to treat depression in adults that have not benefited from other treatments.
The drug, esketamine, is being viewed as a breakthrough akin to the debut of Prozac in the late 1980s.
It can work within hours, so patients don’t have to wait for the ramp-up period that can take weeks with other drugs.
About 5 million Americans who’ve been unable to find help elsewhere — roughly a third of those suffering from major depression — may benefit.
“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” said Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research.
The drug is marketed as Spravato and produced by the Janssen Pharmaceutical Companies of Johnson & Johnson.
Distribution of the drug will be restricted, due to the potential risk of sedation and difficulty with attention, judgment and thinking, regulators said.
For that reason, the drug will carry FDA’s strongest warning, known as a boxed warning because of the border around it on labels.
The spray cannot be used at home — it must be administered in a doctor’s office. The physician will determine when the patient is ready to leave.
• Tom Howell Jr. can be reached at thowell@washingtontimes.com.
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