USFDA clears auricular neurostimulation device
Chennai Company Announces U.S. Food and Drug Administration Clearance for Wearable Medical Device to Treat Drug Addiction
The U.S. Food and Drug Administration has cleared an auricular neurostimulation device manufactured by a Chennai company to treat the symptoms of opioid withdrawal without narcotics. The device, Drug Relief®, is made by DyAnsys India for its U.S. affiliate, DyAnsys Inc.
Drug Relief®, is available by prescription for use during opioid detoxification. This 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.
"This device offers hope to those who are suffering from opioid addiction," said DyAnsys Chief Executive Officer Srini Nageshwar, a graduate of the Institute of Technology Madras. "We are in a full-blown crisis and we need non-narcotic options and alternatives like this that can make a significant difference for individual patients and their families."
Nearly 30 million people, or 0.6 percent of the adult population worldwide, were engaged in problematic drug use and suffered from disorders in 2015, according to the United Nations Office on Drugs and Crime. Opioids accounted for 70 percent of the negative health impact associated with drug use disorders UNDOC reported in last year's World Drug Report.
Drug Relief® is a percutaneous electrical nerve field stimulator designed to administer auricular neurostimulation treatment over 120 hours. The non-addictive treatment allows for continuous nerve stimulation for five days while offering the patient a high degree of comfort and mobility. According to providers, patients may see a reduction in symptoms within 30 to 60 minutes of beginning treatment.
The device eases detoxification, the first step in a comprehensive rehabilitation program. The objective is to relieve symptoms while opioids are cleared from a patient's system. It can be used to stabilize a patient during the early stages of withdrawal without side effects. Stabilization necessary before treating the patient with medication-assisted therapies.