FDA Approves Device to Help with Opioid Withdrawal Symptoms

In 2016, more than 34,500 people died from overdosing on traditional and synthetic opioid painkillers, the National Center for Health Statistics estimates. Beyond that, the opioid epidemic affects millions of Americans, and it only seems to be getting worse.

But help getting off opioids soon may be more readily available for those who seek it. The Federal Drug Administration has approved the NSS-2 Bridge—a medical device that sends small electrical signals to the brain via person’s ear—for use as part of a detox treatment program.

The opioid epidemic affects millions of Americans each year, but a newly approved device may make it easier for people to break their addictions.

Symptoms of opioid withdrawal can be painful and include nausea, anxiety, sweating, tremors, and even insomnia. But in a study of 73 patients, 30% saw a decrease in symptoms after wearing the Bridge for 30 minutes and 88% of them were able to transition to monthly naltrexone shots, which require patients to detox completely from all opioids first.

NOVA Next first covered the Bridge back in April 2017, detailing how patients like Brian Comer have used it to overcome withdrawal from opioid addiction.

Still, some are skeptical of the Bridge’s effectiveness. Beyond being a small sample size, the researchers didn’t conduct a controlled clinical trial. Here’s Max Blau for STAT:

“We don’t know how often [the Bridge] works, and what’s going to happen to patients for whom it doesn’t work,” Jack Mitchell, former director of the FDA’s Office of Scientific Investigations, previously told STAT. “That’s going to be tough to tell without any comparative trials. You just don’t know.”

The Bridge was approved for opioid addiction treatment under an expedited review process for low-risk medical devices, but it’s not the first time it’s been approved by the FDA. In 2014, it was approved for relief of chronic and acute pain. Since then, doctors have been charging between $600 and $1,500 to use it as part of the detox and treatment process for opioids. This new approval would make it eligible for coverage under many people’s insurance plans.