FDA Clears Stimulation Device to Treat Opioid Withdrawal Symptoms
In November 2017, the FDA approved the use of the NSS-2 Bridge neurostimulator to treat symptoms of opioid withdrawal, marking the first time that a medical device has received approval for treatment of withdrawal symptoms.
“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,” said FDA Commissioner Scott Gottlieb, M.D.. “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.”
The NSS-2 Bridge is a small device placed behind the patient’s ear that stimulates nearby cranial and occipital nerves (which run from the spinal cord to the scalp). These simulations provide relief from common withdrawal symptoms during the first few days of drug abstinence, including sweating, tremors, stomach problems, insomnia, and joint pain.
This device is available only by prescription, is strictly intended for short-term use. This limited use is ensured by the fact that each individual device shuts off after 120 hours (five days), noted Tom Carrico, chief regulatory officer of IHS.
In an email to Psychiatric News, Carrico noted that in most cases, five days is long enough to clear the body of opioids and resolve the initial spate of withdrawal symptoms. After this time, the patient is reassessed by a physician for readiness to transfer to medication-assisted treatment (MAT).