WASHINGTON (AP) - A panel of government advisers voted Tuesday to recommend that a device used to treat epilepsy also be permitted to be used in fighting depression.
The vote of the Food and Drug Advisory committee was to approve the treatment, with certain conditions for labeling and physician and patient education.
The device is a pacemaker-like implant sold since 1997 to control certain types of epilepsy. Wires snake up the neck to the vagus nerve, delivering tiny electric shocks through that nerve and on into the brain.
Depression often accompanies epilepsy, and some doctors reported epilepsy patients who felt happier even if the implant failed to reduce their seizures. Researchers found that the vagus nerve leads to a brain region thought to play a role in mood.
Manufacturer Cyberonics Inc. began a 200-patient study to see whether vagus nerve stimulation could treat some of the estimated 10 percent of depression patients not adequately helped by current therapy.
An FDA review concluded that only 15 percent of patients had their depression ease during short-term treatment compared with 10 percent of patients who received a dummy device. But Cyberonics argued that 12-month follow up found up to 30 percent of treated patients had some response, and roughly 15 percent were in remission.
The FDA isn't required to follow the recommendations of its advisory committees, but usually does so.
---
On the Net:
Food and Drug Administration: http://www.fda.gov
