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FDA approves innovative monotherapy for treatment-resistant depression

J&J’s standalone small molecule drug was approved based on evidence of improvement of depressive symptoms without the need for patients to take a daily oral antidepressant.

treatment-resistant depression SPRAVATO

The US Food and Drug Administration (FDA) has approved the first monotherapy for adults with treatment-resistant depression. Johnson & Johnson’s SPRAVATO ® (esketamine) CIII nasal spray is indicated for major depressive disorder (MDD). Approval of this drug system for this indication is supported by positive clinical results demonstrating rapid improvement in depressive symptoms compared to placebo, according to the pharmaceutical company.

At week 4, 22.5 percent of patients taking SPRAVATO achieved remission. This was compared to 7.6 percent of patients given placebo. This data was presented at the 2024 American Society of Psychopharmacology Annual Meeting (Poster W80).

The mechanism of action of SPRAVATO is unique as it targets the N-methyl-D-aspartate (NMDA) glutamate receptor, Johnson & Johnson explained.

“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 antidepressants,” explained Bill Martin, PhD, Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine.

Additional efficacy data for SPRAVATO in treatment-resistant depression

“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 antidepressants”

Results from the ESCAPE-TRD Phase IIIb study of SPRAVATO, showed that esketamine nasal spray significantly increased the number of patients who achieved and reduced the time to PHQ-9 remission. Additionally, participants were 1.21 times as likely to reach remission at Week 32 with SPRAVATO compared to those given extended-release quetiapine. The findings were presented at the 2023 European College of Neuropsychopharmacology Congress (ECNP).

Following this data being shared, Professor Eduard Vieta, Investigator for the ESCAPE-TRD study and Head of the Psychiatry and Psychology Service of the Hospital Clínic de Barcelona, Spain, remarked that it is important to have “treatment options that are less likely to lead to discontinuation for a patient population that is, by its very definition, difficult to treat.”