FDA on Wednesday approved the first medical device to relieve symptoms of opioid withdrawal.
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The NSS-2 Bridge, manufactured by Innovative Health Solutions, is a small battery-powered cranial nerve stimulator. The device is designed to fit behind the ear and emits electrical pulses that stimulate certain branches of the brain to provide patients with relief from opioid withdrawal symptoms—such as anxiety, joint pain, and sweating. The device was approved for use for up to five days during an acute physical withdrawal period.
FDA approved the device based on a clinical study of 73 patients experiencing the physical symptoms of opioid withdrawal. The study evaluated patients' withdrawal symptoms before and after using the device and found all patients experienced at least a 31% reduction in their symptoms. The clinical study showed 88% of patients who used the device transitioned to medication-assisted therapy after five days.
FDA in the approval said the device should not be used by patients who have cardiac pacemakers and those who have been diagnosed with hemophilia and psoriasis vulgaris.
Gottlieb says new treatments for opioid misuse are needed
FDA Commissioner Scott Gottlieb said, "Given the scope of the epidemic of opioid [misuse], we need to find innovative new ways to help those currently addicted live lives of sobriety with the assistance of medically assisted treatment." Gottlieb said there currently are three drugs approved to help individuals with an opioid misuse disorder, but as "we continue to pursue better medicines for the treatment of opioid [mis]use disorder, we also need to look to devices that can assist in this therapy."
Gottlieb said, "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" (AP/Sacramento Bee, 11/15; Bachert, MedPage Today, 11/15; Clarke, Reuters, 11/15).
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