FDA Allows Marketing of Device to Curb Opioid-Withdrawal Symptoms
November 22, 2017   

The US Food and Drug Administration (FDA) has granted marketing authorization for an electric stimulation device to be used in the reduction of symptoms related to opioid withdrawal. It is the first to be granted this indication; three medications (buprenorphine, methadone, and naltrexone) are also approved. The device, NSS-2 Bridge, is a small electrical nerve stimulator that is placed behind the patient's ear and emits electrical pulses to stimulate certain cranial nerves. It can be used for up to five days to relieve the acute physical symptoms of opioid withdrawal. The new indication for NSS-2 Bridge is based on a single-arm clinical study of 73 patients. In the study, all patients showed at least a 31% reduction in scores measuring the severity of the physical symptoms of opioid withdrawal, such as resting pulse rate, sweating, pupil size, gastrointestinal issues, bone and joint aches, tremors, and anxiety. NSS-2 Bridge is available only by prescription; contraindications for its use include hemophilia, psoriasis vulgaris, or the presence of a cardiac pacemaker.

FDA press release

     Interested in learning more about opioid dependence and its treatment? NEI Members can access:

Encore Presentation:
Lightning Round Cases: Opioid Therapy IS Associated With Abuse and Misuse: Tips to Manage It in Your Practice
Encore Presentation:
Lightning Round Cases: Treatments for Opioid Dependence