Already on its way to becoming a blockbuster drug, Johnson & Johnson’s Spravato has received another potential boost as the FDA has blessed the nasal spray to be used as a monotherapy for major depressive disorder (MDD).

Spravato was originally approved in 2019 to be used along with an oral antidepressant for patients who have not seen results with other antidepressant medications.

In 2020, the U.S. regulator tacked on another nod for Spravato to be used by patients with MDD who experience acute suicidal thoughts or behavior.

The standalone endorsement allows patients to use Spravato without taking oral antidepressants. Spravato can work as quickly as 24 hours, Bill Martin, Ph.D., who heads up J&J neuroscience, said in a release.

“Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them," Martin added. "For too long, healthcare providers have had few options to offer patients much-needed symptom improvement."

The label expansion is based on results from a trial that showed Spravato provided improvements over placebo in all 10 of the categories in the Montgomery-Asberg Depression Rating Scale (MADRS). After 28 days, 22.5% of patients on Spravato attained remission versus 7.6% of patients in placebo. With MDD, remission is defined by a specified MADRS score.

Because of the risk of dangerous outcomes from misuse of Spravato, its availability is regulated through a Risk Evaluation and Mitigation Strategy program.

Through the first three quarters of 2024, Spravato generated sales of $780 million, which was a 62% increase from the same period in 2023.