Innovative Health Solutions Inc.
It will take more than medication alone to win the battle against opioid addiction, and now U.S. clinicians finally have a device-based therapy to help reduce the symptoms of opioid withdrawal. FDA granted a new indication to Innovative Health Solutions for its NSS-2 Bridge nerve stimulator. The new indication was reviewed under FDA's de novo pathway.
“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,” said FDA Commissioner Scott Gottlieb, MD.
Gottlieb said FDA supports the development of both drug and device-based treatments 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 NSS-2 Bridge device is a small electrical nerve stimulator placed behind the patient’s ear. It contains a battery-powered chip that emits electrical pulses to stimulate branches of certain cranial nerves. Such stimulations may provide relief from opioid withdrawal symptoms, the agency noted. The device is placed behind the ear with microneedle arrays that percutaneously implant in and around the ear.
Patients can use the device for up to five days during the acute physical withdrawal phase. Opioid withdrawal causes acute physical withdrawal symptoms including sweating, gastrointestinal upset, agitation, insomnia, and joint pain.
The NSS-2 Bridge is one of several emerging devices that could help curb opioid use.
FDA reviewed data from a single-arm study of 73 patients undergoing opioid physical withdrawal. The study evaluated patients' clinical opiate withdrawal scale (COWS) score, which is a clinical assessment conducted by a healthcare professional that measures opioid withdrawal symptoms. COWS scores range from 0 to more than 36, the higher the number, the more severe the symptoms are to a patient.
Prior to using the device, the average COWS score for all patients was 20.1. Study results showed that all patients had a reduction in COWS of at least 31% within 30 minutes of using the device. Overall, 64 of the 73 patients (88%) transitioned to medication-assisted therapy after five days using the device, along with any medications needed for persistent symptoms, such as nausea and vomiting.
The FDA cleared the EAD (electro auricular device, now called Bridge Neurostimulation System) in 2014 for use in acupuncture. FDA’s granting of the current request for the NSS-2 Bridge expands the use of the device as an aid to reduce the symptoms of opioid withdrawal. It is available only by prescription. The device is contraindicated in patients with hemophilia, patients with cardiac pacemakers or those diagnosed with psoriasis vulgaris.
“Our vision is for every person in withdrawal, preparing for withdrawal, or suffering from post-acute withdrawal symptoms (PAWS), to have access to this technology,” said Brian Carrico, president of IHS. “Significantly reducing withdrawal symptoms lessens the dependency on opioids, allows for easier transition to medically assisted treatment (MAT) and ultimately works as another tool to combat the opioid epidemic facing our country.”
Withdrawal symptoms from opioids can manifest quickly and include nausea, diarrhea, vomiting, abdominal pain, anxiety, and sleeplessness. Most often these symptoms are so painful and overwhelming, people turn back to opioids after only a few hours, IHS noted.
“The technology gives those suffering from opioid addiction an easier transition to all forms of MAT,” said Carrico. “The device helps take away the fear of withdrawal and leads to a much higher success rate.”