Cyberonics revamps depression study
This article was originally published in The Gray Sheet
Executive Summary
Revised plan for IDE study is recently filed by the company for the NeuroCybernetic Prosthesis vagus nerve stimulation system in treating depression. The plan is designed to determine the statistical significance of one-year outcomes in Cyberonics' 12-week, 235-patient D-02 study, which initially failed to demonstrate the benefit of NCP over placebo in treating refractory depression (1"The Gray Sheet" Jan. 28, 2002, p. 19). In subsequent discussions with the company, FDA has "recognized the need for new treatments for pharmaco-resistant depression, reconfirmed VNS therapy's expedited review status and reiterated that until FDA has reviewed the one-year data, they believe another randomized, controlled study will be required," VP-Regulatory Affairs & Quality Alan Totah says Nov. 6...