FDA Approves IN Company's Device Aimed Ease Opioid Withdrawal

The U.S. Food and Drug Administration has granted a company approval for its device aimed at helping to reduce opioid withdrawal symptoms. According to a release from the FDA, the NSS-2 Bridge device is a small electrical nerve stimulator that's placed behind a patient's ear. It releases electrical pulses from a battery-powered chip, which the FDA says stimulates the branches of certain nerves in the cranium. The FDA says these stimulations may provide relief from opioid withdrawal symptoms, and can be used for up to five days.

The company behind this newly approved device is Innovative Health Solutions in Versailles, Indiana.

According to the FDA, opioid withdrawal causes acute physical withdrawal symptoms which include sweating, insomnia, join pain, agitation and gastrointestinal upset.

“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," FDA Commissioner Scott Gottlieb, M.D., said in a release. "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. 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.”

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According to the FDA, marketing of the device was allowed after the review of data from a clinical study of 73 patients who were going through opioid physical withdrawal. The FDA said the study:

• Evaluated patients’ clinical opiate withdrawal scale (COWS) score, which according to the FDA is "A clinical assessment conducted by a health care professional that measures opioid withdrawal symptoms such as resting pulse rate, sweating, pupil size, gastrointestinal issues, bone and joint aches, tremors and anxiety."
• COWS scores range from 0 to more than 36, and the higher the number, the more severe the withdrawal symptoms are to a patient.

According to the FDA, the average COWS score for all patients before using the new device was 20.1. But within 30 minutes of using the device, the FDA says study results showed all patients had a decrease in COWS of at least 31 percent.

The study found 64 of the 73 patients (88 percent) transitioned to medication assisted therapy after five days using the device, along with any medications needed for persistent symptoms.

More information: fda.gov

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