FDA Grants Marketing to Opioid Withdrawal Device

The US Food and Drug Administration (FDA) has approved an electric stimulation device for the reduction of opioid withdrawal symptoms.

The NSS-2 Bridge, a small elective nerve stimulator that emits electrical pulses to stimulate branches of cranial nerves, can be used for up to 5 days during the acute physical withdrawal phase.

Placed behind patient’s ears, the device treats withdrawal symptoms such as sweating, gastrointestinal upset, agitation, insomnia, and joint pain.

FDA Commissioner Scott Gottlieb, MD said, in the midst of the opioid epidemic, there is a need to find innovative ways to “help those currently addicted live lives of sobriety with the assistance of medically assisted treatment.”

“There are three approved drugs for helping treat opioid addiction. 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,” Gottlieb said.

The FDA had approved Innovative Health Solutions’ device for opioid withdrawal therapy based on clinical data of 73 patients. The study evaluated their clinical opiate withdrawal scale (COWS) score, a measured by withdrawal symptoms on a scale from 0 to 36 — with higher numbers indicating more severe symptoms.

Patients reported a mean COWS score of 20.1 at baseline. Following 30 minutes of therapy with the device, all patients reported a score reduction of at least 31%.

Follow 5 days of being treated with the device, 64 (88%) of the patients transitioned to medication-assisted therapy.

The FDA had cleared the electro auricular device (EAD) for acupuncture indications in 2014, marketed as the Bridge Neurostimulation System. The expanded-use approval for opioid withdrawal will make the device available by prescription.

“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,” Gottlieb said.

A press release regarding the approval was made available.