The US Food and Drug Administration (FDA) has authorised Innovative Health Solutions to market its electric stimulation device, NSS-2 Bridge, to minimise opioid withdrawal symptoms.
Designed to be placed behind the ear, NSS-2 Bridge is a nerve stimulator with a battery-powered chip that emits electrical pulses to stimulate select cranial nerve branches.
The device is indicated for up to five days of use during the physical withdrawal phase, which includes symptoms such as sweating, gastrointestinal upset, agitation, insomnia and joint pain.
FDA Commissioner Scott Gottlieb said: “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 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.”
The FDA approval is based on the data obtained from a single-arm clinical study performed in 73 patients who were undergoing opioid physical withdrawal.
As per the study results, within 30 minutes of using the device, all patients experienced a minimum of 31% reduction during a clinical assessment of withdrawal symptoms called COWS scores.
Following five days of device use, 83% of patients are reported to have transitioned to medication-assisted therapy.
The current approval expands the original indication of the Bridge Neurostimulation System cleared by the FDA in 2014 for use in acupuncture.