Questioning the standards used to back esketamine

Since its approval earlier this year, Janssen’s esketamine has offered a distinct alternative to the standard SSRI or electroshock regimens previously offered to patients with treatment-resistant depression.

But a new Lancet piece outlines concern that the trial standards for testing esketamine were quite lax — and could lower the bar for future evaluation of mental health drugs. For instance, several patients in the Phase 3 trial had only failed one class of antidepressants before being admitted into the esketamine study — meaning they didn’t qualify for the standard definition of “treatment resistant.” And the patients weren’t required to have tried — and failed — at psychotherapy. 

The article outlines seven different concerns about the validity of the drug. A separate Lancet piece also expresses concern about esketamine — and calls into question brexanolone, a Sage Pharmaceuticals drug approved this year for postpartum depression. 

The authors say they “are concerned that these approvals share common critical features, and could further lower the bar in the evaluation of treatments for mental disorders.”