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The NSS-2 Bridge is a small device placed behind the patient’s ear that emits electrical pulses to stimulate cranial nerves. These stimulations provide relief from common withdrawal symptoms during the first few days of drug abstinence; these include sweating, tremors, stomach problems, insomnia, and joint pain.
“Given the scope of the epidemic of opioid addiction, we need to find innovative new ways to help those currently addicted live lives of sobriety with the assistance of medically assisted treatment,” said FDA Commissioner Scott Gottlieb, M.D., in a press announcement. “While we continue to pursue better medicines for the treatment of opioid use disorder, we also need to look to devices that can assist in this therapy.”
The FDA marketing approval was granted based on an open-label pilot study of the effects of the nerve stimulator on 73 patients undergoing opioid physical withdrawal. The study found that the average clinical opiate withdrawal scale (COWS) scores of the participants dropped by about 63% after 20 minutes of use, and 85% after 60 minutes. After five days of use, 64 of the 73 participants (88%) successfully transitioned to medication-assisted treatment (MAT). Successful transition to MAT was defined as “those who returned to the clinic and received their first dose of maintenance medication,” the study authors noted in a report published in March in the American Journal of Drug and Alcohol Abuse.
The FDA reviewed the NSS-2 Bridge device through the de novo premarket review pathway, a regulatory pathway that fast-tracks low- to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can be compared. The device was developed by Innovative Health Solutions Inc., and was cleared by the FDA in 2014 for use in acupuncture.
To read more about this topic, see the Psychiatric News article “FDA Clears First Prescription-Based ‘Digital Therapeutic.”