FDA Grants Standalone Approval for Novel Nasal Spray Antidepressant Spravato (Esketamine)

The U.S. Food and Drug Administration has broadened its endorsement of Spravato, an antidepressant nasal spray. The medication is now approved for application as a solo therapy for depression.

Spravato is derived from esketamine, one of the two enantiomers present in the anesthetic ketamine. It received approval in 2019 for utilization in adults suffering from major depressive disorder who have not benefited from at least two other antidepressants.

The initial approval mandated that patients using Spravato also receive an oral antidepressant. Now, the FDA indicates that the drug can be utilized independently. This decision followed a substantial study which revealed that Spravato alone performed better than a placebo. In the first nine months of 2024, the drug yielded approximately $780 million in sales for its manufacturer, Johnson & Johnson.

Administering Spravato requires direct oversight by a healthcare professional.

In the company’s press announcement regarding the expanded application, it emphasized that depression is intricate and the medication could lead to, “serious adverse effects resulting from sedation, dissociation, respiratory depression, abuse, and misuse,” thus it will continue to be administered in certified treatment centers.

Major depressive disorder impacts over 20 million adults in the U.S. Approximately one in three individuals do not react to oral antidepressants alone.