Research supports the use of Spravato nasal spray in adults with major depressive disorder.
The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) has announced results from its ESCAPE-TRD study – a long-term, randomised, open-label phase 3b clinical trial designed to evaluate the short and long-term efficacy, safety and tolerability of Spravato.
The nasal spray – also known as esketamine – is being compared to the existing treatment quetiapine, both in combination with a continuing selective serotonin reuptake inhibitor or serotonin and a norepinephrine reuptake inhibitor. The tests all involve adults with major depressive disorder (TRD).
The study, which evaluated 676 adults in total, demonstrated that esketamine, as a nasal spray, met its primary endpoint, showing superior efficacy in achieving remission at week eight compared to quetiapine. It also met its key secondary endpoint, with more participants reaching remission at week eight and remaining relapse-free up to week 32.
“People living with TRD experience significant disruption and impairment to their lives, and there is an urgent and ongoing need to identify therapies to effectively address what can be a devastating condition,” reflected Dr Tamara Werner-Kiechle, EMEA therapeutic area lead, neuroscience and pulmonary hypertension at Janssen.
She concluded: “The findings from the ESCAPE-TRD trial are an important step towards helping people who have not responded to multiple previous treatment cycles, being able to get the respite they need.”
Professor Andreas Reif, who led the trial, explained: “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.”
“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,” he added.