Policy & Regulation
Spravato Data from the Phase 3b ESCAPE-TRD Study Demonstrate Superior Efficacy Compared to Quetiapine Extended-Release in Treatment-Resistant Major Depressive Disorder
23 November 2022 - - US-based healthcare company Johnson & Johnson's (NYSE: JJJ) Janssen business has posted 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, both in combination with a continuing selective serotonin reuptake inhibitor or serotonin and norepinephrine reuptake inhibitor, in adults with treatment-resistant major depressive disorder, the company said.

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 XR.

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 32.

The trial evaluated 676 adults with TRD, randomised to receive either esketamine NS (n=336) or quetiapine XR (n=340), both in combination with a continuing SSRI/SNRI.

TRD was defined as non-response to at least two consecutive adequately-dosed treatments (including the ongoing treatment) during the current depressive episode.

The primary endpoint assessed rates of remission† while on study treatment at Week 8 between the two trial arms and demonstrated that significantly more participants achieved remission in the esketamine NS arm compared to the quetiapine XR arm (27.1% vs. 17.6% respectively; p=0.003).

The key secondary endpoint of the trial was remaining relapse free while on study treatment at Week 32, after achieving remission at Week 8.

Significantly more participants achieved remission at Week 8 with no relapse at Week 32 in the esketamine NS arm compared to the quetiapine XR arm (21.7% vs. 14.1% respectively; p=0.008).

In addition, remission rates continued to increase in both arms after the primary endpoint at Week 8 with a significantly greater proportion of patients in remission at Week 32 in the esketamine NS arm versus the quetiapine XR arm (55% vs 37%; p