Positive results announced in phase 3 study of intranasal esketamine for TRD

Janssen has announced positive results from the phase 3 ESCAPE-TRD trial, which evaluated flexibly dosed intranasal esketamine for treatment-resistant major depressive disorder.

According to a company release, the trial evaluated Spravato (esketamine, Janssen) compared with quetiapine extended release, both in combination with a continuing selective serotonin reuptake inhibitor or serotonin and norepinephrine reuptake inhibitor (SNRI). A total of 676 adults participated, who were randomized to receive either esketamine NS (n = 336) or quetiapine XR (n = 340), both in combination with a continuing SSRI/SNRI.

Results of the long-term, comparative, randomized, open-label study were revealed at the German Association for Psychiatry, Psychotherapy and Psychosomatics Congress on Nov. 23. Data showed that esketamine NS met its primary endpoint of demonstrating superior efficacy in achieving remission at week 8 compared with quetiapine XR. The study also met its key secondary endpoint, demonstrating that not only did significantly more participants treated with esketamine NS compared with quetiapine XR achieve remission while on study treatment at week 8, the individuals also remained relapse-free up to week 32.

“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,” Andreas Reif, MD, principal investigator for the trial and head of the department of psychiatry, psychosomatic medicine and psychotherapy at University Hospital Frankfurt in Germany. “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 TRD.”

Per the release, the most common treatment-emergent adverse events observed in the esketamine NS arm were dizziness (46.7%), nausea (29.3%), dissociation (28.1%), headache (24.6%), vertigo (18.9%), somnolence (15%), dysgeusia (12%), paresthesia (11.1%) and vomiting (10.8%). In the quetiapine XR arm, the most common adverse events were somnolence (23.2%), weight increase (12.5%) and headache (12.8%).