J&J’s Janssen Reports Favorable Spravato Data in Late-Stage TRD Trial

Johnson & Johnson’s (J&J; NYSE: JNJ) subsidiary, Janssen, has presented tolerability and efficacy data from a late-stage trial comparing its antidepressant Spravato (esketamine nasal spray) with oral quetiapine in the treatment of treatment-resistant major depressive disorder (TRD). The trial evaluated both drugs in combination with serotonin reuptake inhibitors (SRIs).

Trial Outcomes and Tolerability
While the Spravato arm experienced more treatment-emergent adverse events (TEAEs), a higher proportion of these were transient compared to the quetiapine cohort (92.1% vs 12.1% of TEAEs). Additionally, a higher rate of TEAEs resolved on the same day in the Spravato group (82.6% vs 15.5% of TEAEs), and persisted for more than one day less frequently (53.6% vs 74.7% of patients). Importantly, a lower rate of TEAEs led to treatment discontinuation in the Spravato arm (4.2% vs 11.0% of TEAEs).

Efficacy and Remission Rates
In terms of efficacy, Spravato demonstrated higher remission rates at week 8 compared to quetiapine (56.8% vs 43.3%) and maintained this trend at week 32 (68.9% vs 57.2%). These results suggest that Spravato may offer a more effective treatment option for patients with TRD, particularly in achieving and sustaining remission.

Conclusion
The late-stage trial data presented by Janssen highlight the potential advantages of Spravato in managing TRD, particularly in terms of efficacy and the transient nature of adverse events. As Janssen continues to explore the therapeutic potential of Spravato, these findings could have significant implications for the treatment landscape of TRD.-Fineline Info & Tech

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