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FDA Clears Wearable Device to Treat Opioid Addiction
The FDA has cleared a new auricular neurostimulation device (Drug Relief, DyAnsys, Inc.), to be used as an aid to reduce the symptoms of opioid withdrawal without narcotics. The device is available for providers to prescribe for use during opioid detoxification. The wearable device sends electrical pulses through tiny needles inserted in the ear to alleviate symptoms such as anxiety, agitation, depression, nausea, opiate cravings, and more.
An estimated 11.5 million Americans 12 years of age and older misused prescription pain medicine in 2016, according to the Substance Abuse and Mental Health Services Administration. More than 2.5 million Americans suffer from opioid use disorder, according to the National Institutes on Drug Abuse.
The Drug Relief device is a percutaneous electrical nerve field stimulator designed to administer auricular neurostimulation treatment over 120 hours. The nonaddictive treatment allows for continuous nerve stimulation over five days while offering the patient a high degree of comfort and mobility. According to providers, patients may see a reduction in the symptoms of opioid withdrawal within 30 to 60 minutes of beginning treatment.
The device eases the process of detoxification, which is the first step in a comprehensive rehabilitation program. The objective is to ease symptoms while opioids are cleared from a patient's system. It can be used to help stabilize a patient during the early stages of withdrawal without side effects. Stabilization is a necessary first step before treating the patient with medication-assisted therapies such as naltrexone.
Source: PRNewswire; June 12, 2018.