FDA Clears Transcutaneous Auricular Neurostimulation for Opioid Withdrawal Symptoms

Clinical trial (NCT04075214) results showing that a wearable transcutaneous auricular nerve field stimulator (tAN) (Sparrow Therapy System; Spark Biomedical, Dallas, TX) reduced opioid withdrawal symptoms led to FDA clearance for the therapy. 
The therapy uses an earpiece that delivers tAN that stimulates nerves on and around the ear. The earpiece is designed to be worn up to 24 hours a day throughout opioid reduction or as prescribed to aid in the reduction of symptoms. 

Over a 12-month period, 26 participants were enrolled in a randomized, controlled trial to determine the effectiveness of tAN therapy.   
Therapy effectiveness was measured using the 11-point Clinical Opioid Withdrawal Scale (COWS). The therapy achieved the primary endpoint by demonstrating a clinically meaningful reduction in withdrawal symptoms (>15%) within the first 60 minutes of therapy. 

Participants received tAN therapy for up to 5 days, and on days 2 through 5, all participants sustained a meaningful reduction in withdrawal symptoms (eg, tremor, gooseflesh skin, gastric distress). The study will be completed in early 2021.   
The therapy is intended to be used in conjunction with standard symptomatic medications and other therapies under the supervision of trained clinical personnel.

“These achievements highlight the potential of tAN as a new treatment approach for neurologic and psychiatric disease,” said Navid Khodaparast, PhD, co-founder and chief science officer, Spark Biomedical “From the beginning, our objective was to design a clinical trial that would demonstrate a meaningful treatment effect and promote confidence in patients and families suffering from opioid use disorder. We are grateful for the FDA’s decision.”