FDA Approves First Device for Opioid Withdrawal
This week, the U.S. Food and Drug Administration (FDA) granted marketing approval for an electric stimulation device to reduce symptoms of opioid withdrawal. According to FDA Commissioner Scott Gottlieb, M.D., the agency is committed to developing new treatment options, including drugs and devices, to address the opioid epidemic.
The device, called NSS-2 Bridge, is a small electrical nerve stimulator that is placed behind the patient’s ear and emits impulses that stimulate branches of certain cranial nerves. This stimulation may help relieve opioid withdrawal symptoms, which can include sweating, gastrointestinal upset, agitation, insomnia and joint pain. The device can be used for up to five days during the acute physical withdrawal phase.
Prior to marketing approval, the FDA reviewed data from a study involving 73 people undergoing opioid physical withdrawal. The study evaluated withdrawal symptoms using a clinical assessment tool that provides a score between 0 and 36. (Higher scores indicate more severe symptoms.) Within 30 minutes of using the electric stimulation device, all patients experienced at least a 31 percent reduction in their scores.