The opioid addiction epidemic is a growing public health concern in the United States. Instead of being a powerful painkiller for terminal patients, the drugs have become deadly. Deaths from drug overdoses reached an all-time high of 63,600 in 2016.
To put that in perspective, it represents a 21% increase from previous years and is the most significant single-year jump ever. Roughly 42,000 of those overdose deaths were from opioids. It's estimated that more than 11 million people in the United States struggle with opioid addiction and that number is likely low since many who are hooked on the heavy-duty pain pills do not seek treatment. The Food and Drug Administration recently approved a device that those who are trying to beat the addiction can use to ease withdrawal symptoms.
FDA Commissioner Scott Gottlieb, M.D., explained in 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. 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."
The device, an electro auricular device, is called the NSS-2 Bridge and it is worn behind a patient's ear. It's battery-powered and similar in size to a hearing aid. It emits electrical pulses to specific cranial nerves. These impulses can ease some of the more severe withdrawal symptoms that patients experience, which include sweating, stomach upset, joint pain, insomnia, and agitation. It can be worn for up to five days, which is the usually the hardest part of withdrawal.
The device was approved for marketing based on a study involving 73 patients who were undergoing withdrawal from opiates. In recovery from opioid addiction, healthcare professionals use a rating scale to measure the severity of several withdrawal symptoms and indicators. They include resting pulse rate, pupil size, sweating, tremors, bone and joint pain and agitation/anxiety. Called a COWS score (Clinical Opiate Withdrawal Scale) it ranges from 0 to as high as 36 depending on the patient, the time since last use and other factors.
Before using the device, COWS scores for the patients were about 20, which is moderate to severe withdrawal. Within 30 minutes of putting on the device, every patient had a reduction in their symptom severity, as evidenced by a drop in COWS ratings of at least 31%. Many patients who are in recovery from opioid addiction also go on to use medication for relief from more persistent symptoms of addiction such as nausea, vomiting, and fatigue. In the FDA study, 88% of patients changed over from the Bridge to medication.
It's not the first go-round for The Bridge at the FDA. In 2014 it was approved for use in acupuncture. The approval for use in addiction recovery is an expansion of use, and the right to market the device was assigned to Innovative Health Solutions, Inc. Patients who have hemophilia, psoriasis vulgaris or who wear a cardiac pacemaker cannot use the device. Check out the video below to hear about some of the first patients to use The Bridge for recovery.