J&J's nasal spray Spravato bests former AZ drug Seroquel XR in treatment-resistant depression trial

Johnson & Johnson’s esketamine nasal spray continues to build a body of evidence showing it can go toe-to-toe with tough-to-treat depression.

Wednesday, J&J’s Janssen unit rolled out data from the phase 3b ESCAPE-TRD trial pitting its esketamine spray Spravato against extended-release quetiapine, formerly marketed by AstraZeneca as Seroquel XR before the British drugmaker pawned off the rights to Cheplapharm in late 2019.

Seroquel and Seroquel XR are primarily used to treat schizophrenia and bipolar disorder. Their patents have lapsed in the U.S., meaning generics are widely available.

In the study of patients with treatment-resistant major depressive disorder, J&J’s Spravato bested extended-release quetiapine in helping subjects hit remission on the Montgomery-Åsberg Depression Rating Scale at the trial’s eight-week mark, Janssen said in a release. Spravato also met its key secondary endpoint by helping patients remain relapse-free up to 32 weeks.

ESCAPE-TRD looked at a total of 676 adults with treatment-resistant depression (TRD), 336 of whom received Spravato, compared with 340 on extended-release quetiapine. Both cohorts were also given a continuing selective serotonin reuptake inhibitor or a serotonin and norepinephrine reuptake inhibitor.

Digging deeper into the results, 27.1% of Spravato patients hit remission at eight weeks, versus 17.6% of patients on quetiapine. Further, remission rates for patients on Spravato continued to increase after that time, with 55% in remission at 32 weeks compared with 37% of patients in the comparator cohort. 

On the trial's secondary endpoint, 21.7% of Spravato patients remained relapse-free at treatment at the study's 32-week mark, versus 14.1% of patients on quetiapine.

Spravato won FDA approval back in 2019 based on phase 3 data comparing it to placebo and an oral antidepressant. At the time, J&J touted data showing that patients with TRD in remission who continued to take Spravato were 51% less likely to relapse versus those who maintained a regimen of placebo and an oral antidepressant.

The drug left the starting gate bearing blockbuster expectations and a steep price tag, with public sources currently pinning the cost of two 28-mg Spravato doses at around $730 before discounts.

While Janssen has previously defended the value of its nasal spray, the drug’s high cost has triggered past snubs from cost watchdogs on both sides of the Atlantic.

But in an unusual turn of events earlier this fall, an appeals panel ruled that England’s National Institute for Health and Care Excellence may have erred in its recent rejection of Janssen’s Spravato for TRD.

And in one positive sign for the launch, the U.S. Department of Veterans Affairs in 2019 said it would make the drug available for veterans.