The Janssen Pharmaceutical Companies of Johnson & Johnson has reported that the Phase IIIb ESCAPE-TRD clinical trial of Spravato (esketamine nasal spray [NS]) for treatment-resistant major depressive disorder (TRD) in adult patients met its primary endpoint.
The long-term, comparative, open-label, rater-blinded, active-controlled, randomised, global, multicentre trial analysed the safety, short- and long-term efficacy, and tolerability of flexibly dosed esketamine NS versus quetiapine XR.
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In the trial, both treatments were given along with a continuing selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI).
Carried out in 24 countries in Latin America, Europe, Africa, and Asia, the trial enrolled a total of 676 adult patients with TRD.
The primary endpoint of the trial evaluated remission rates at week eight.
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According to the findings, substantially more subjects, or 27.1%, in the esketamine NS arm attained remission versus 17.6% in the quetiapine XR arm at week eight.
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By GlobalDataThe trial’s key secondary endpoint of subjects continuing to be relapse-free at week 32 after achieving remission at week eight was also met.
Nealy 21.7% of the subjects treated with esketamine NS that achieved remission while on the study treatment at week eight were found to be relapse free up to week 32 versus 14.1% in the quetiapine XR arm.
Dizziness, nausea, dissociation, headache, vertigo, and somnolence, among others, were found to be the most frequent treatment-emergent adverse events (TEAEs) seen in subjects who received esketamine NS.
These findings were in line with the safety profile seen in prior trials.
Esketamine NS is an N-methyl-D-aspartate (NMDA) glutamate receptor antagonist.
Janssen Pharmaceutical Companies of Johnson & Johnson Janssen-Cilag GmbH Neuroscience and Pulmonary Hypertension EMEA therapeutic area lead Dr Tamara Werner-Kiechle said: “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.”
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