FDA OKs Marketing of Device to Reduce Opioid Withdrawal Symptoms

Officials with the FDA have permitted marketing of the first device for use in reducing symptoms of opioid withdrawal.

With the approval of its new indication, the Innovative Health Solutions’ NSS-2 Bridge electrical stimulation device can be used in patients for up to 5 days during the acute physical withdrawal phase, to provide relief from symptoms such as sweating, gastrointestinal upset, agitation, insomnia, and joint pain. The device is a small electrical nerve stimulator that is placed behind the patient’s ear and emits electrical pulses to stimulate branches of certain cranial nerves.

The approval is based on data from a single-arm clinical study reviewed by the FDA. In the study, 73 patients who underwent opioid physical withdrawal were evaluated based on their clinical opiate withdrawal scale (COWS). COWS is a clinical assessment that measures opioid withdrawal symptoms, such as resting pulse rate, sweating, pupil size, gastrointestinal issues, bone and joint aches, tremors, and anxiety. Scores range from 0 to more than 36, with the higher scores representing more severe symptoms.

The average COWS score for patients in the study prior to using the device was 20.1. Within 30 minutes of using the device, patients showed a reduction in COWS of at least 31%. Eighty-eight percent of the trial participants transitioned to medication assisted therapy after 5 days of using the device, along with any medications needed for persistent symptoms, such as nausea and vomiting.

The FDA reviewed the device through the de novo premarket review pathway, which is a regulatory pathway for some low- to moderate-risk novel devices for which there is no legally marketed predicate device to which the device can claim substantial equivalence.

The device was approved by the FDA in 2014 for the use of acupuncture.

Reference

FDA grants marketing authorization of the first device for use in helping to reduce the symptoms of opioid withdrawal [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585271.htm?utm_campaign=11152017_PR_FDA%20allows%20marketing%20of%20opioid%20withdrawal%20device&utm_medium=email&utm_source=Eloqua. Accessed November 15, 2017.