FDA approves device to reduce opioid withdrawal symptoms
The Food and Drug Administration today authorized Innovative Health Solutions Inc. to market an electrical nerve stimulator device to relieve opioid withdrawal symptoms when placed behind the patient’s ear. Previously approved for use in acupuncture, the NSS-2 Bridge device reduced symptoms for patients undergoing opioid withdrawal during a clinical study by at least 31% within 30 minutes, based on the clinical opiate withdrawal scale. Sixty-four of the 73 patients in the study transitioned to medication assisted therapy after five days using the device. “The FDA is committed to supporting the development of novel treatments, both drugs and devices, that can be used to address opioid dependence or addiction, as well as new, non-addictive treatments for pain that can serve as alternatives to opioids,” said FDA Commissioner Scott Gottlieb, M.D.