Credit: Johnson & Johnson. The approval of Spravato for the monotherapy indication in TRD was supported by data from the randomized, double-blind, placebo-controlled, phase 4 TRD4005 trial.

Spravato is classified as a Schedule III controlled substance and is only available through a restricted program called the Spravato REMS. The Food and Drug Administration (FDA) has approved ...

Kelsey Warren [email protected]  609 218 4053 Investor contact: Lauren Johnson [email protected] ...

the treatment is available only through the Spravato REMS program. Common AEs include temporary increased blood pressure; issues with thinking clearly; bladder problems; nausea; dizziness; drowsiness; ...

Spravato is the first monotherapy for adults with major depressive disorder who had an inadequate response to at least two oral antidepressants. It is available only through a restricted REMS program.

Given its potential for abuse and misuse, Spravato will be only available through the FDA's Risk Evaluation and Mitigation Strategy (REMS) Program.

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However, Spravato remains restricted under the FDA's REMS program due to its abuse potential. Investors will watch how this regulatory win impacts Johnson & Johnson's pharma segment ahead of earnings.