Magazine article Clinical Psychiatry News

FDA Clears First-Ever Neurostimulation Device for Opioid Withdrawal Symptoms

Magazine article Clinical Psychiatry News

FDA Clears First-Ever Neurostimulation Device for Opioid Withdrawal Symptoms

Article excerpt

The Food and Drug Administration has cleared a medical device that uses electrical stimulation to cranial nerves, and head and neck nerves to reduce acute opioid withdrawal symptoms.

The clearance was granted amid the opioid crisis, which experts say is killing 175 Americans each day. Currently, opioid addiction is treatable by three approved medications, said FDA Commissioner Scott Gottlieb, MD, in a press statement announcing the agency's decision to permit marketing of the NSS-2 Bridge device.

The device was cleared as an acupuncture aid in 2014. The new use of the device to reduce the symptoms of opioid withdrawal required a new clearance, which was granted based on a single, one-arm clinical study. In the study, 73 patients who were experiencing physical withdrawal from opioids used the device. They reported an initial mean score of 20.1 on the Clinical Opiate Withdrawal Score (COWS). All patients using the device had a reduction of at least 31% on the COWS within 30 minutes of beginning use of the NSS-2 Bridge. Almost 90% of participating patients transitioned to medication-assisted treatment after 5 days of using the device. …

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