FDA gives clearance for opioid addiction withdrawal treatment
The FDA gave clearance for a neurological device with an indication to aid in the reduction of opioid withdrawal symptoms. The NSS-2 BRIDGE device, pioneered by Indiana-based medical technology firm Innovative Health Solutions (IHS), is placed behind the ear with micro-needle arrays that percutaneously implant in and around the ear. Research study results of the technology show an 84.6% reduction of withdrawal symptoms in as little as 60 minutes. The NSS-2 BRIDGE device is a patented technology and is Rx (prescription) only.
“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.
“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.”
With this FDA clearance, doctors will now be able to prescribe treatment using the NSS-2 BRIDGE device to patients who are in withdrawal, along with patients suffering from PAWS. This FDA clearance makes the device eligible for insurance coverage as soon as states and commercial carriers adopt the technology.