FDA Authorizes Device for Opioid Withdrawal Treatment

The FDA granted a new indication to an electric stimulation device that reduces the symptoms of withdrawal among patients seeking treatment for opioid use disorder, according to a press release.

“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.

The NSS-2 Bridge device delivers an electrical nerve stimulator that is placed behind the ear. The device contains a chip that transmits electrical pulses to stimulate cranial nerves, which may provide relief from opioid withdrawal symptoms, including sweating, gastrointestinal upset, agitation, insomnia, and joint pain, according to the release.

The device is indicated to treat patients for up to 5 days during the withdrawal phase.

The expanded approval was based on findings from a clinical trial that included 73 patients experiencing opioid withdrawal. Investigators evaluated effects through the clinical opiate withdrawal scale (COWS) score, which assesses withdrawal symptoms such as pulse rate, sweating, pupil size, gastrointestinal issues, bone and joint aches, tremors, and anxiety, according to the release.

Prior to using the device, the average score was 20.1. The addition of the NSS-2 Bridge device was observed to reduce COWS scores more than 31% within 30 minutes, according to the FDA. Notably, 88% of patients went on to receive medication-assisted treatment after 5 days of device use.

These findings suggest that the addition of the device may help patients seek further treatment for opioid use disorder.

Previously, the device was approved for use in acupuncture. Under the expanded indication, patients can access the device through a prescription.

The FDA warns that the device is contraindicated in patients with hemophilia, a pacemaker, or psoriasis vulgaris, according to the release.

“There are 3 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,” Dr Gottlieb said. “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.”