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FDA approves marketing of first-ever gadget to manage opioid withdrawal symptoms

Posted on 11-21-2017 Posted in Addiction - 0 Comments

FDA approves marketing of first-ever gadget to manage opioid withdrawal symptoms

As the United States continues its battle with opioid crisis, the Food and Drug Administration (FDA) is looking for other non-addictive and innovative ways to help the ones currently suffering from opioid addiction. A new device called NSS-2 Bridge was recently approved by the agency to alleviate the withdrawal symptoms associated with opioid addiction. The device was first marketed in 2014 by Indiana-based company Innovative Health Solutions for managing acute and chronic pain. Now, it can also be sold to ease off the symptoms of opioid withdrawal but can be sold only through prescription.

The device is a battery-operated electrical nerve stimulator attached to the ear. It emits signal through four cranial nerves to help reduce the withdrawal symptoms, such as aches, nausea and anxiety. Patients can use the device for up to five days when they experience acute physical symptoms.

The device has been in use by doctors from Alaska and Florida for quite some time. They charge patients anywhere from $600 to $1500 for incorporating this device during their detox regimen. Doctors have shared that this device helped their patients avoid relapsing before starting the therapy with naltrexone. Given the extent of worsening opioid epidemic, the device could have a potential to facilitate sobriety in people taking medically-assisted therapy. “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,” said FDA Commissioner Dr. Scott Gottlieb.

Device has shown limited effectiveness, say certain quarters

According to patient safety advocates, the device has shown limited effectiveness against the claims of the company. Moreover, it has not been tested in a clinically controlled trial yet. The FDA gave approval based on a study that incorporated 73 subjects who were evaluated on the opiate withdrawal scale in terms of their pupil size, tremors, joint and bone pain, pulse rate, etc.

Some 88 percent of the study population had successfully navigated to the medication assisted therapy after five days of using the device. Jack Mitchell, former director of the FDA’s Office of Scientific Investigations, expressed his doubts by stating that, “We don’t know how often [the Bridge] works, and what’s going to happen to patients for whom it doesn’t work. That’s going to be tough to tell without any comparative trials. You just don’t know.” This was substantiated by Dr. Lance Dodes from Harvard Medical School who has penned down multiple books on addiction. He said that if the researchers were patient enough to do a pilot, followed by a controlled study, the results could have been far-reaching.

Need to tackle opioid mayhem

The opioid crisis has ravaged such an entire country to the extent that it has been declared a public health emergency by the federal government. Despite the unrelenting efforts of the state and federal bodies, there has been no respite from its effects. The Centers for Disease Control and Prevention (CDC) estimates that at least six out of 10 drug overdose deaths involve an opioid. Since 1999, deaths due to opioids like oxycodone, methadone and hydrocodone have almost gone up four times. On an average, nearly 91 Americans die due to opioid overdose each day.

Opioid addiction can be treated with well-timed medical intervention. Sovereign Health of Florida offers excellent facilities for treatment of opioid addiction and other substance abuse-related problems. Using scientific and evidence-based treatment methodologies, our competent and empathetic staff at our drug addiction treatment center in Florida provide help to patients seeking relief. Call our 24/7 helpline or chat online for more information related to our finest drug rehab facilities in Florida.

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