Device to Help Reduce Symptoms of Opioid Withdrawal Gets FDA Approval
A device designed to provide relief from opioid withdrawal symptoms when placed behind the ear has been granted marketing authorization by Food and Drug Administration (FDA).
The NSS-2 Bridge device (Innovative Health Solutions, Inc.) is a small electrical nerve stimulator that emits electrical pulses to stimulate branches of certain cranial nerves. The device can be used for up to 5 days during the acute physical withdrawal phase. Opioid withdrawal commonly causes symptoms including sweating, gastrointestinal upset, agitation, insomnia and joint pain.
The FDA approval is supported by a single-arm clinical study of 73 patients undergoing opioid physical withdrawal. The participants had their clinical opiate withdrawal scale (COWS) score evaluated before and after using the NSS-2 Bridge device. The device led to a ≥31% reduction in COWS for all patients within 30 minutes of initiating use.
The electro auricular device (EAD) was previous cleared by the FDA in 2014 for use in acupuncture. “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,” FDA Commissioner Scott Gottlieb, MD, said in a statement.
The device is only available through prescription and is contraindicated for patients with hemophilia, with cardiac pacemakers or those diagnosed with psoriasis vulgaris.
For more information visit FDA.gov.