The U.S. Food and Drug Administration (FDA) announced on November 15 the approval of a device called the Neuro-Stim System Bridge (NSS-2 Bridge), which is meant to help reduce the symptoms of opioid withdrawal. It’s the first medical device of its kind that’s been given the FDA’s blessing.
The NSS-2 Bridge is a relatively simple device that attaches to the skin behind the ear, where it uses a chip to transmit controlled electrical pulses to stimulate four cranial nerves in the part of the brain that’s associated with processing pain information.
Marketed by Indiana-based Innovative Health Solutions, the Bridge was previously cleared to treat chronic and acute pain in 2014. The new approval “expands the use of the device as an aid to reduce the symptoms of opioid withdrawal,” according to the FDA, though it will only be available by prescription. It is rather pricey though, with previous Bridge treatments costing between $600 and $800.
There’s little to suggest how broadly effective this treatment could be, however. The FDA granted permission for the device after reviewing data from a clinical study that worked with “73 patients undergoing opioid physical withdrawal,” the announcement says. The trials showed that 64 out of these 73 patients, or 88 percent, successfully transitioned away from opioids after five days of using the Bridge. There is clearly efficacy here, although the number of respondents could’ve been higher.
An opioid addiction treatment device is still welcome news, particularly since abusive use of opioids has continued to be menace in American society. The National Institutes on Drug Abuse reports that some 90 Americans die every day from opioid overdose, and a lot of this comes from misuse of prescription pain relievers, as well as overdose from heroin and synthetic opioids like fentanyl.
Meanwhile, the Centers for Disease Control and Prevention (CDC) notes that prescription opioid misuse costs the U.S. around $78.5 billion a year, from healthcare expenses, loss productivity, addiction treatment and from criminal justice involvement.
“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 said in the press announcement. “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 noted that there are already three approved drugs for treating opioid addiction, but the FDA remains “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.”
Indeed, there are a number of other efforts to combat the opioid epidemic, including an app that tracks opioid overdoses all over the U.S. in real-time. Others are looking to artificial intelligence (AI) to find solutions, while some are testing devices that could replace non-addictive painkillers. In order to put an end to the opioid crisis, it’s also necessary to improve on our knowledge of how drug-seeking behavior works.