New Safety Data Suggests Esketamine Nasal Spray Spravato is more tolerable and effective compared to Quetiapine Extended-Release (XR) in adults with treatment-resistant major depressive disorder

October 9, 2023 Off By Author

 The new safety data is from the ESCAPE-TRD Phase 3b study, which showed esketamine NS demonstrated a significant increase in the proportion of patients achieving remission and response compared to quetiapine XR, based on the patient-reported Patient Health Questionnaire (PHQ-9)2

BEERSE, BELGIUM, 8 October 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced further findings for SPRAVATO® (esketamine nasal spray [NS]) from the ESCAPE-TRD study. Data on treatment-emergent adverse events (TEAEs) suggest a more favourable tolerability profile in adults with treatment-resistant major depressive disorder (TRD) receiving esketamine NS than quetiapine XR.

Across all reported TEAEs experienced with esketamine NS, 92.1 percent were transient and resolved the same-day vs 12.1 percent of TEAEs experienced with quetiapine XR.1

The findings were presented at the 36th European College of Neuropsychopharmacology Congress (ECNP 2023) taking place from 7 October to 10 October in Barcelona, Spain. While more TEAEs were observed with esketamine NS than with quetiapine XR, a greater proportion of esketamine NS-treated patients (82.6 percent) reported a TEAE that resolved same-day day vs quetiapine XR patients (15.5 percent).1

Fewer esketamine NS-treated patients (53.6 percent) reported a TEAE that persisted for more than one day vs quetiapine XR-treated patients (74.7 percent) and TEAEs leading to treatment discontinuation were more frequent with quetiapine XR (11.0 percent) than with esketamine NS (4.2 percent).1

“From a clinician’s perspective, each decision for treating a patient is based on a thorough evaluation of the treatment’s benefits and risks, with patient safety being of paramount importance,” said Professor Eduard Vieta, Investigator for the ESCAPE-TRD study and Head of the Psychiatry and Psychology Service of the Hospital Clínic de Barcelona, Spain.1

“The findings from the ESCAPE-TRD study give confidence to healthcare professionals treating those living with TRD. 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.”