FDA Deems Cyberonics' VNS Therapy System Approvable for TRD

Cyberonics has announced that the FDA deemed the Vagus Nerve Stimulation (VNS) Therapy System approvable as a long-term adjunctive treatment for patients over the age of 18 with chronic or recurrent treatment-resistant depression (TRD) in a major depressive episode that has not responded to at least four adequate antidepressant treatments.

In the approvable letter, the FDA indicated that final approval was conditional on final labeling, final protocols for a postapproval dosing optimization study and patient registry, satisfactory compliance with quality system regulations, and satisfactory resolution of any outstanding bioresearch monitoring issues.

Stimulation is delivered by the VNS Therapy System, an implantable generator similar to a cardiac pacemaker that delivers preprogrammed intermittent mild electrical pulses to the vagus nerve in the patient's neck 24 hours a day. If approved, the VNS Therapy System will be the first implantable device-based treatment for depression, and the first treatment developed, studied and labeled specifically for patients with treatment-resistant depression, the company said.