FDA OKs behind-the-ear device for opioid withdrawal
Innovative Health Solutions has bagged an FDA clearance for its nerve field stimulator that treats the symptoms of opioid withdrawal.
The NSS-2 Bridge device is placed behind the ear, with microneedle arrays implanted near nerve endings found in and around the ear, the company says. It delivers electrical impulses to four cranial and occipital nerves to help reduce withdrawal symptoms.
Withdrawal symptoms can appear as few as eight hours after last using opioids and can include nausea and vomiting, anxiety, muscle cramps and insomnia. According to World Health Organization guidelines, treating mild symptoms involves hydration, nutritional supplements, such as vitamin C, and symptomatic treatment. More severe cases may require treatment with clonidine or opioid medications such as buprenorphine or methadone.
“Our vision is for every person in withdrawal, preparing for withdrawal, or suffering from post-acute withdrawal symptoms (PAWS), to have access to this technology,” said Brian Carrico, president of Innovative Health Solutions. “Significantly reducing withdrawal symptoms lessens the dependency on opioids, allows for easier transition to Medically Assisted Treatment (MAT) and ultimately works as another tool to combat the opioid epidemic facing our country.”
The approval sets the ball rolling for insurance coverage. Physicians were previously using the Bridge device off-label for people addicted to opioids, STAT News reported.
Last summer, Titan Pharma and Braeburn Pharma scored an FDA nod for their buprenorphine implant, designed to treat opioid dependence. The device continuously delivers a constant, low dose of the drug over six months. Buprenorphine is available as a pill or film that requires patients to self-administer their treatment daily. An implant approach aims to improve patient adherence and deter misuse. Meanwhile, Pear Therapeutics and MAP Health Management are using digital health tools to treat substance abuse.
In addition to addressing withdrawal symptoms, medtech players are also working on solutions to prevent addiction in the first place. Medtronic and Abbott market spinal cord stimulation systems, which are nonopioid treatments for chronic pain, and a number of startups are working on neurostimulation devices for various types of pain.