FDA clears first opioid withdrawal device
FDA granted a new indication to a device that can help reduce the symptoms of withdrawal from the prescription pain drugs.
Providing another tool for clinicians to use in the opioid abuse crisis, FDA granted a new indication to a device that can help reduce the symptoms of withdrawal from the prescription pain drugs.
FDA granted the new indication to the NSS-2 Bridge device (Innovative Health Solutions), a small electrical nerve stimulator placed behind the patient’s ear. The device contains a battery-powered chip that emits electrical pulses to stimulate branches of certain cranial nerves, which may provide relief from opioid withdrawal symptoms, according to a statement from FDA.
Related: Activists: drugmakers, distributors liable for opioids abuse
“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,” said FDA Commissioner Scott Gottlieb, MD, in the statement.
“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,” Gottlieb added.
Related: FDA advisors recommend 2 opioid use disorder drugs
FDA first cleared the EAD (electro auricular device, now called Bridge Neurostimulation System) in 2014 for use in acupuncture. It is available only by prescription.
To permit marketing of the device for this use, FDA reviewed data from a single-arm clinical study of 73 patients undergoing opioid physical withdrawal. Prior to using the device, the average clinical opiate withdrawal scale (COWS) score for all patients was 20.1. After using the device, patients had a reduction in COWS of at least 31% within 30 minutes.
In addition, 88% of patients transitioned to medication-assisted therapy after 5 days of using the device, along with any medications needed for persistent symptoms, such as nausea and vomiting.
The device is contraindicated for patients with hemophilia, patients with cardiac pacemakers or those diagnosed with psoriasis vulgaris.
Read more: FDA alters stance on opioid addiction drugs
