The Janssen Pharmaceutical Companies of Johnson & Johnson recently unveiled pivotal findings on SPRAVATO® (esketamine nasal spray) from the ESCAPE-TRD study at the 31st European Congress of Psychiatry.
The ESCAPE-TRD study was an international phase 3b clinical trial conducted across 24 countries, designed to assess the effectiveness, safety, and tolerability of esketamine NS versus quetiapine XR, both used alongside ongoing SSRI or SNRI treatments for individuals with TRD. The study involved 676 adults, with 336 receiving esketamine NS and 340 given quetiapine XR, all for up to 32 weeks. The study was structured into a preliminary 14-day screening, an 8-week acute treatment phase, a 24-week maintenance phase, and a concluding 2-week safety follow-up after the last treatment dose.
Here's a breakdown of these groundbreaking insights:
1. About TRD and MDD: Major Depressive Disorder (MDD) affects nearly 40 million individuals in the EU. An alarming one-third of these patients do not find relief from standard treatments and fall under the category of Treatment-Resistant Major Depressive Disorder (TRD).
2. Study Highlights: The ESCAPE-TRD study pitted esketamine nasal spray against quetiapine extended-release (XR), with both combined with either an SSRI or SNRI. The study involved 676 adults suffering from TRD:
- Esketamine users experienced notably higher remission rates from the 6th week and response rates from the 15th day throughout the 32-week study compared to those on quetiapine XR.
- By Week 32, 55% of esketamine users achieved remission, contrasting with 37% in the quetiapine XR group.
- Response rates at Week 8 were 55.4% for esketamine vs. 39.1% for quetiapine XR, which increased to 75.5% and 55.5%, respectively, by Week 32.
- Esketamine also led to a significant reduction in depressive symptoms as gauged by the MADRS from Day 8.
3. Expert Commentary: Professor Andreas Reif, the lead investigator, highlighted the clinical significance of esketamine's benefits over time, offering hope to those grappling with TRD. Dr. Tamara Werner-Kiechle from Janssen echoed this sentiment, emphasizing the potential of esketamine nasal spray in transforming the treatment landscape for TRD.
4. Safety Concerns: The study also revealed a lower treatment discontinuation rate due to adverse events for esketamine (4.2%) than quetiapine XR (11%). Dizziness, dissociation, and vomiting were some reasons for esketamine discontinuation, while sedation, weight increase, and somnolence were cited for quetiapine XR.
In essence, the ESCAPE-TRD study shines a promising light on esketamine nasal spray as a formidable treatment for those wrestling with the challenges of TRD, marking a significant stride in mental health therapeutics.
To learn more about Spravato you can visit our other blog post here or here and our service page here.