FDA Panel Recommends Approval of Vagus Nerve Stimulation for Depression

Cyberonics, Inc., the Houston, TX manufacturer of vagus nerve stimulation systems, announced that the Neurological Devices Panel of FDA’s Medical Devices Advisory Committee voted 5 to 2 on June 15 to recommend approval with conditions of the company’s VNS therapy “as an adjunctive long-term treatment of chronic or recurrent depression for patients over the age of 18 who are experiencing a major depressive episode that has not had an adequate response to four or more adequate antidepressant treatments.”

Regarding conditions, the panel recommended several labeling changes: that VNS depression prescribers and implanting surgeons have appropriate experience and adequate training in the implantation and programming of the system, that patients receive adequate education, and that Cyberonics implement a long-term depression patient registry following approval. FDA’s Division of General and Restorative Neurological Devices will make the final decision on approval of VNS for the proposed indication for use.

“The Panel’s recommendation represents a major step forward toward U.S. availability of the first FDA-approved, safe, tolerable, and effective long-term treatment for patients with treatment-resistant depression,” said Skip Cummins, Cyberonics chairman and CEO. “Millions of Americans today suffer from treatment-resistant depression (TRD), a devastating, lifelong, and life-threatening illness. According to published studies, 15 percent of previously hospitalized patients commit suicide and annual depression treatment costs in the United States exceed $30 billion including $13.7 billion for drugs alone. Today’s panel vote suggests that not only was there agreement on the significant unmet need, but also that the comprehensive one-year data and analyses on 460 patients included in Cyberonics PMA-Supplement demonstrated the safety and effectiveness of VNS therapy as an adjunctive long-term treatment for chronic or recurrent treatment-resistant depression.

“Cyberonics is looking forward to working with FDA to finalize labeling that will ensure informed use of VNS therapy, implement the panel’s recommendations and obtain a timely approvability decision,” continued Cummins.“The recommended conditions are consistent with Cyberonics depression plans and epilepsy history, including the proposed depression patient registry, which will be similar to our existing epilepsy registry. The panel’s vote is a tribute to the patients, families, psychiatrists, and other clinicians whose courage, determination, and pioneering spirit made the last six years of depression clinical studies possible.

“Cyberonics mission is to improve the lives of people touched by epilepsy, depression, and other chronic illnesses that prove to be treatable with our patented therapy, VNS,” concluded Cummins. “The plan to accomplish our mission in epilepsy in fiscal 2005 has been implemented and the plan to properly scale our organization to accomplish our mission in depression will be implemented as soon as we are confident of depression approval.”

Major Depressive Disorder (MDD) is one of the most prevalent and serious illnesses in the U.S., affecting nearly 19 million Americans over the age of 18 in any given year. MDD is the second most disabling condition for the general population and the most disabling condition for females in the U.S. Approximately 9.5 million Americans are treated annually for depression and MDD is associated with increased mortality due to suicide and comorbid general medical conditions including heart disease and stroke. Depressed patients use twice the healthcare services as non-depressed patients. Total annual costs of depression in the U.S. exceed $80 billion including $30 billion of annual direct treatment costs.

Most psychiatrists agree that TRD is a major depressive episode that has not had an adequate response to two or more adequate antidepressant treatments at appropriate dose and duration. Twenty percent of depressed Americans or approximately 4 million people suffer from TRD. Patients with TRD are often isolated, hopeless, desperate, and unemployed and frequently visit the emergency room and are hospitalized. Studies show that annual healthcare costs for patients with TRD exceed $40,000 per patient per year.

A person with depression is 35 times more likely to commit suicide than a person not experiencing depression and 15 percent of previously hospitalized depressed patients commit suicide. Although there are many safe and effective acute antidepressants including medications, psychotherapy, and electro-convulsive therapy (ECT), there are no FDA-approved, informed-use, safe and effective long-term treatments for TRD. Multiple medication combinations are used to treat TRD without evidence of long-term safety and efficacy. ECT, the most effective acute antidepressant, is often declined, and is of limited long-term value due to cognitive side effects and high relapse/recurrence rates within six months of treatment.