(RxWiki News) The US Food and Drug Administration (FDA) has approved the marketing of the first device meant to help reduce opioid withdrawal symptoms.
The NSS-2 Bridge device is an electric nerve stimulator to be placed behind the ear. It sends electric pulses to certain nerves to relieve some of the symptoms of opioid withdrawal. The device can be used for five days during the acute physical withdrawal period, according to the FDA.
“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 Dr. Scott Gottlieb in a press release. "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."
When people take opioids, which are strong pain medications, and then quit taking these drugs, they often experience physical withdrawal symptoms. These symptoms include sweating, stomach upset, agitation, difficulty sleeping and joint pain.
Before approving the NSS-2 Bridge device, the FDA examined data from a study of the device that included 73 patients who were experiencing opioid physical withdrawal. During the study, the patients' clinical opiate withdrawal scale (COWS score) was evaluated. The COWS score is an assessment that measures withdrawal symptoms.
Within a half hour of using the device, all of the patients saw a reduction in COWS of at least 31 percent, according to the FDA.
People who have pacemakers, hemophilia or psoriasis may not use this device, the FDA noted.
If you are concerned about your opioid use, ask your health care provider for help.
Innovative Health Solutions, Inc., markets the NSS-2 Bridge device.