WASHINGTON -- A first-in-class neurostimulation device to relieve symptoms of opioid withdrawal is approved for marketing, the .
The NSS-2 Bridge device is a small, battery-powered electrical nerve stimulator that is placed behind a patient's ear and emits electrical pulses to stimulate branches of certain cranial nerves. Patients can use the device for up to 5 days during the acute physical withdrawal phase.
The device, made by Innovative Health Solutions, was previously cleared by the FDA in 2014 for use in acupuncture.
"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, MD, in an agency press release. "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."
Device approval was based on a study that evaluated the clinical opiate withdrawal scale (COWS) score -- measuring symptoms on a scale of 0 to more than 36 (0 being the least severe) -- in 73 patients undergoing opioid physical withdrawal. Study results showed that all patients had a reduction in COWS of at least 31% within 30 minutes of using the device and that 88% of patients transitioned to medication-assisted therapy after 5 days.
The device is available only by prescription and is contraindicated for patients with hemophilia, cardiac pacemakers, and psoriasis vulgaris.