Spravato (esketamine) demonstrates superior efficacy compared to quetiapine extended-release in treatment-resistant major depressive disorder – Johnson & Johnson

An open-label, international study published in the New England Journal of Medicine found that patients receiving Spravato (esketamine) CIII nasal spray for treatment-resistant depression (TRD) were 1.54 times as likely to reach remission after eight weeks than those treated with quetiapine extended-release (XR) at Week 8, (27.1% vs. 17.6%, respectively). Spravato-treated patients were also 1.55 times as likely to stay relapse-free up to 32 weeks after achieving remission at Week 8, without treatment discontinuation, in comparison to those treated with quetiapine XR (21.7% vs. 14.1%, respectively).

The publication shows for the first time the full breadth of data from ESCAPE-TRD, a randomized, open-label, rater-blinded, active-controlled, ex- U.S. study comparing Spravato and quetiapine XR, both in conjunction with an oral antidepressant, in adults with TRD. Spravato is indicated along with an oral antidepressant to treat adults with TRD and to treat depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions.

Adverse events and treatment discontinuation rates observed in the study were consistent with the established safety profile of Spravato and quetiapine XR treatments. Treatment-emergent adverse events occurred in 92% of Spravato-treated patients compared to 78% of quetiapine XR-treated patients. 4.2% of Spravato-treated patients and 11% quetiapine XR-treated patients discontinued medication due to an adverse event.

Key study limitations for the ex- U.S. ESCAPE-TRD trial are its open-label study design, differences in treatment compliance and routes of administration between the groups, and differences in patient touchpoints between the two arms. However, the study design better reflects real-world practice by enabling the sites, all located outside of the U.S., to administer treatment according to their respective prescribing labels.

“This large head-to-head trial gives physicians important data to consider in the management of treatment-resistant depression by comparing the short- and long-term effectiveness of Spravato to an oral antipsychotic,” said Reina Benabou, M.D., Ph.D., Vice President, Medical Affairs, Neuroscience, Janssen Scientific Affairs, LLC. “Spravato offers patients an additional important option. It is critical that those living with this difficult-to-treat condition have choices to consider for their personal treatment plans, in discussion with their healthcare providers.”

About ESCAPE-TRD1 : Escape-TRD is a randomized, open-label, rater-blinded, active-controlled, international, multicenter phase IIIb clinical study designed to evaluate the efficacy, safety and tolerability of flexibly dosed esketamine NS compared with quetiapine XR, both in combination with a continuing selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors in subjects with TRD. Select data from ESCAPE-TRD was previously presented at medical congresses in 2022 and 2023.

See- “Esketamine Nasal Spray versus Quetiapine for Treatment-Resistant Depression”.- Andreas Reif, M.D., Istvan Bitter, M.D., Ph.D., D.Sc., Jozefien Buyze, Ph.D., Kerstin Cebulla, M.Sc., Richard Frey, M.D., et al., for the ESCAPE-TRD Investigators.-October 5, 2023N Engl J Med 2023; 389:1298-1309.DOI: 10.1056/NEJMoa2304145.