Back to All Events

Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

The committees met to discuss the efficacy, safety, and risk-benefit profile of a new drug application (NDA) for esketamine nasal spray, submitted by Janssen Pharmaceuticals, Inc. (Janssen), for the treatment of treatment-resistant depression (TRD). The votes of the joint committee supported approval.

A majority of the joint committee, 14 of 17 members, voted that Janssen has provided substantial evidence of the effectiveness of esketamine for the treatment of treatment-resistant depression (TRD). Two committee members voted that the company has not provided substantial evidence of effectiveness for the proposed use. One member abstained from voting.

A majority of the joint committee, 15 of 17 members, voted that Janssen has adequately characterized the safety profile of esketamine for the treatment of TRD. Two committee members voted that the safety profile was not adequately characterized.

A majority of the joint committee, 14 of 17 members, voted that, given the effectiveness and safety of esketamine and the FDA’s proposed risk evaluation and mitigation strategy (REMS), the benefits outweigh the risks of esketamine for the treatment of TRD.