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.
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.”
In August this year, the company reported final findings from the Phase II GRIFFIN trial of Darzalex (daratumumab) plus lenalidomide (Revlimid), bortezomib (Velcade), and dexamethasone (Darzalex-RVd) in multiple myeloma patients.
