Spark Biomedical has completed enrollment for two pivotal clinical trials investigating transcutaneous auricular neurostimulation (tAN) therapy as a novel treatment approach for opioid-related conditions. The Dallas-based medical device company announced the completion of enrollment for studies targeting both adult opioid use disorder and neonatal opioid withdrawal syndrome, representing significant milestones in developing non-invasive alternatives to traditional opioid-based treatments.
Adult Opioid Use Disorder Trial
The company's pivotal study for adult opioid use disorder addresses a critical public health challenge, with relapse rates exceeding 70% among individuals with the condition. Synthetic opioids like fentanyl continue to drive overdose deaths to record highs, creating an urgent need for innovative interventions.
The trial, funded by the National Institute on Drug Abuse (NIDA) under the HEAL Initiative, was conducted in partnership with the Hazelden Betty Ford Foundation and Gaudenzia. The study investigated wearable transcutaneous auricular neurostimulation as a method to improve both acute and long-term recovery outcomes.
"Completing enrollment marks a critical milestone in advancing transcutaneous auricular neurostimulation as a non-invasive, drug-free therapy for opioid use disorder," said Dr. Navid Khodaparast, Spark Biomedical's Co-founder and Chief Science Officer. "This study not only evaluates the standalone efficacy of wearable neurostimulation in enhancing treatment retention but also explores its potential to synergize with established pharmacotherapies."
The trial examined the potential synergistic effects of tAN therapy combined with two approved medications for opioid use disorder: lofexidine and XR-naltrexone. By helping individuals stay engaged in treatment longer, the study aims to support lasting recovery without additional opioid-based medications.
Dr. Alta DeRoo, Chief Medical Officer at Hazelden Betty Ford Foundation, emphasized the study's significance: "This pivotal trial represents non-pharmaceutical options to treat opioid withdrawal. In addition to FDA-approved medications for opioid use disorder, this non-pharmaceutical option will empower patients in their treatment options. This provides us with more weapons and a hopeful step forward in combatting one of the most urgent public health challenges of our time."
Neonatal Opioid Withdrawal Syndrome Trial
Spark Biomedical also completed enrollment for its pivotal phase II clinical trial targeting newborns with Neonatal Opioid Withdrawal Syndrome (NOWS). The study, conducted at The Medical University of South Carolina, UT Southwestern Medical Center, and the University of Texas Health Science Center at San Antonio, investigated how non-invasive tAN therapy could reduce the need for prolonged opioid treatment in affected infants.
The trial focused on infants over 33 weeks gestational age who experienced severe withdrawal symptoms including tremors, irritability, and difficulty feeding as a result of in-utero opioid exposure. Researchers examined how tAN therapy, when combined with current morphine treatments, affected the time required for medical readiness for discharge.
"Following FDA Breakthrough Device Designation, the SPROUT trial was the next step in moving us closer towards an FDA approval of a non-invasive neurostimulation treatment for NOWS infants," Dr. Khodaparast explained. Participants are now being monitored for two years to assess long-term neurodevelopmental outcomes.
Clinical Development Strategy
Each year, thousands of infants begin life affected by NOWS, representing some of the most vulnerable victims of the opioid epidemic. Daniel Powell, Spark Biomedical's CEO, highlighted the company's commitment to addressing this population: "Since the first days of Spark, we've had the vision to create a version of our neurostimulation platform designed specifically for the most vulnerable victims of the opioid epidemic."
The company's neurostimulation platform, branded as Sparrow Fledgling for the pediatric indication, has received FDA Breakthrough Device Designation. Once data analysis is complete, Spark plans to submit the device to the Food and Drug Administration for approval.
Both trials were funded by NIDA under the HEAL Initiative, reflecting federal commitment to developing innovative approaches to address the opioid crisis. The completion of enrollment in these pivotal studies positions Spark Biomedical to potentially bring the first non-invasive neurostimulation therapies for opioid-related conditions to market, offering healthcare providers new tools beyond traditional pharmacological interventions.
