Janssen has announced results from ESCAPE-TRD, a long-term, comparative, randomised, open-label phase 3b clinical trial designed to evaluate the short- and long-term efficacy, safety and tolerability of flexibly dosed SPRAVATO® (esketamine nasal spray [NS]) compared with quetiapine extended-release (XR), both in combination with a continuing selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI), in adults with treatment-resistant major depressive disorder (TRD)1.
The findings, presented at the German Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN) Congress, showed that esketamine NS met its primary endpoint, demonstrating superior efficacy in achieving remission at Week 8 compared to quetiapine XR1. The study also met its key secondary endpoint, demonstrating that not only did significantly more participants treated with esketamine NS compared to quetiapine XR achieve remission while on study treatment at Week 8, they also remained relapse free up to Week 321.
Professor Andreas Reif, Principal Investigator for the ESCAPE-TRD trial and Head of Department, Department of Psychiatry, Psychosomatic Medicine and Psychotherapy at University Hospital Frankfurt, Germany* said: “Achieving remission and remaining relapse free are major milestones in the treatment of depression and are especially challenging in TRD, where patients have not responded to previous therapies. The ESCAPE-TRD findings showed that esketamine nasal spray enabled a significantly greater percentage of patients to achieve remission at Week 8 and remain relapse free in the longer term up to Week 32 compared to quetiapine extended-release. This provides further evidence for the use of esketamine nasal spray in this difficult-to-treat population and offers hope for the millions of people affected by TRD2,3.”
Dr. Tamara Werner-Kiechle, EMEA Therapeutic Area Lead, Neuroscience and Pulmonary Hypertension, Janssen-Cilag GmbH, part of the Janssen Pharmaceutical Companies of Johnson & Johnson said: “People living with TRD experience significant disruption and impairment to their lives, and there is an urgent and ongoing need to identify therapies to effectively address what can be a devastating condition. We are pleased to see that esketamine nasal spray has been demonstrated to be effective and well-tolerated versus a strong augmentation comparator treatment in enabling people to achieve the goals of achieving remission and remaining relapse free up to 32 weeks – important and meaningful milestones in treating TRD. Today’s findings from the ESCAPE-TRD trial are an important step towards helping people who have not responded to multiple previous treatment cycles, being able to get the respite they need.”
References
1 Reif A. et al., Esketamine nasal spray improves short and long term outcomes compared with quetiapine extended release in patients with treatment resistant depression: First results from ESCAPE TRD, a randomised, multi centre phase IIIb clinical trial. Presented at DGPPN 2022, November 23-26. Poster P-01-04.
2 World Health Organization (WHO). Raising awareness of depression. Available at: https://www.who.int/europe/activities/supporting-country-work-around-mental-health/raising-awareness-of-depression. Last accessed: November 2022.
3 Ionescu DF, et al. Dialogues Clin Neurosci 2015;17(2):111–126.
