Drugmakers to FDA: Lift Monotherapy Restriction in MDD Guidance

Janssen and Takeda called for more flexibility in the FDA’s draft guidance for sponsors of drugs that treat major depressive disorder (MDD).

Janssen said it disagreed with the agency’s proposal to limit treatment-resistant depression (TRD) studies to monotherapies. The company is currently developing a ketamine-based nasal spray for major depressive disorder that combines esketamine with an oral antidepressant. In May, Janssen unveiled Phase III clinical study results indicating a statistically significant reduction of depressive symptoms.

Takeda also called for more flexibility in trial designs in the final guidance. “In accordance with American Psychiatric Association clinical practice guidelines, TRD patients should be included in adjunctive or combination therapy trials in cases where the studies are properly designed and scientifically sound,” the company said.