The United States Food and Drug Administration (FDA) has given a green signal to the marketing of an electrical nerve stimulator designed to alleviate symptoms of opioid withdrawal. The device, developed by an Indiana-based medical technology manufacturer, is authorized for use by patients with opioid addiction during the acute withdrawal phase.
According to the FDA, rampant opioid addiction across the country warrants the need of innovative ways to help addicted people lead a sober life. According to FDA Commissioner Dr. Scott Gottlieb, while the three approved drugs under the medically assisted treatment (MAT) have shown remarkable results, the federal agency continues to look for innovative devices that can complement this therapy. “The 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,” Gottlieb said.
The device — NSS-2 Bridge — is a small electrical nerve stimulator equipped with a battery-operated chip. When placed behind the patient’s ear, the chip transmits electrical pulses that stimulate branches of certain cranial nerves. These stimulations help the patients overcome opioid withdrawal symptoms. The device can be used for up to five days by anyone experiencing acute physical withdrawal symptoms like sweating, insomnia, agitation, gastrointestinal problems, anxiety, vomiting and joint pain.
The decision to approve the device was taken after the FDA was convinced with its efficacy. The federal agency analyzed data from a clinical study carried on 73 patients experiencing physical opioid withdrawal. It reported at least 31 percent relief in withdrawal symptoms among all patients within 30 minutes of using the device. Overall, 88 percent patients from the group were shifted to MAT after five days using the device, along with the medications needed to manage persistent symptoms like vomiting and nausea.
The FDA has allowed NSS-2 Bridge as an aid to deal with the symptoms of opioid withdrawal. Available only by prescription, the device is contraindicated for patients with cardiac pacemakers or those diagnosed with hemophilia or psoriasis vulgaris, an autoimmune disorder characterized by patches of abnormal skin.
Opioid epidemic in US
The 2016 National Survey on Drug Use and Health (NSDUH) has reported opioid misuse in 11.8 million Americans aged 12 or older in the past year. The opioid abuse was highly prevalent in young adults aged 18 to 25, with an annual prevalence of 7.3 percent in the past year. According to the Centers for Disease Control and Prevention (CDC), 33,000 opioid-related deaths were reported in 2015, with prescription drugs attributing to half of all opioid overdose fatalities. In 2014, around 53,000 people were hospitalized, while an estimated 92,262 visited emergency department (ED) for non-fatal unintentional opioid poisoning.
Considering the gravity of the problem, President Donald Trump has already declared the opioid crisis a public health emergency. People should also support their government to tackle this emergency. Opioid addiction is treatable with timely medical interventions. Typically, treatment of drug addiction commences with a detoxification program, which helps manage withdrawal symptoms, clears the body of the drugs and prepares it for the further course of treatment.
If you have a loved one struggling with an addiction, encourage him or her to seek professional help immediately. Sovereign Health, one of the leading drug detox centers in California, follows a systematic detox program to help people with opioid addiction recover. Call at our 24/7 helpline number 855-682-0103 for more information on our drug detox clinics in California. You can also contact one of our representatives through online chat.