The US Food and Drug Administration (FDA) has granted marketing authorisation to an electric stimulation device aimed at helping to reduce the symptoms associated with opioid withdrawal.
Approval
The NSS-2 Bridge device is a small electrical nerve stimulator to be placed behind a patient’s ear. Containing a battery-powered chip that emits electrical pulses to stimulate branches of certain cranial nerves, the device can be used for up to five days to alleviate symptoms of opioid withdrawal, such as sweating, gastrointestinal upset, agitation and insomnia.
“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. 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,” stated FDA commissioner Dr Scott Gottlieb. “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.”
In reaching its decision, the FDA reviewed data from a single-arm clinical study that evaluated 73 patients undergoing physical opioid withdrawal symptoms. A clinical assessment was used to determine efficacy of the device with all patients reporting a reduction in severity of symptoms of at least 31% within 30 minutes of using the device.
The device is only available by prescription and is contraindicated for patients with haemophilia, cardiac pacemakers or those diagnosed with psoriasis vulgaris. This marketing authorisation has been granted to the device manufacturer Innovative Health Solutions.