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 ...

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.

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® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks ... be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023 ...

TITUSVILLE, N.J., Jan. 21, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA ...

Gregory Mattingly, MD, president, Midwest Research Group, founding partner, St. Charles Psychiatric Associates, discusses the immediate impact Spravato has had on patients ... or more antidepressants.

"SPRAVATO ® is now available as a standalone treatment, meaning patients may experience improvements in depressive symptoms as early as 24 hours and at 28 days – without the need for daily oral ...