Withdrawal symptoms and NICU stay reduced to days instead of weeks.

Dallas, TX, Aug 4, 2020 — While instances of Neonatal Opioid Withdrawal Syndrome (NOWS) are still on the rise, and the eyes of the nation remain focused on a pandemic, the Medical University of South Carolina (MUSC) and Spark Biomedical, Inc. are tackling opioid withdrawal in newborns — the most innocent victims of the still-looming opioid crisis. This groundbreaking clinical trial pairs Spark’s Transcutaneous Auricular Neurostimulation (tAN™) device for newborns — the Roo — with the pediatric neurostimulation expertise and facilities of MUSC to develop a safe and more effective withdrawal relief solution for NOWS.

In most instances, newborns undergoing NOWS experience tremors, high-pitched crying, seizures, feeding difficulties, gastric discomfort, and temperature instability. To alleviate symptoms, oral morphine, an opioid with additional side-effects, is administered. The morphine therapy is then gradually weaned down over a two to four-week period, with the average hospital stay lasting 21 days —all spent in a NICU setting at an average cost of $53,000 per newborn, according to a study published in the US National Library of Medicine, National Institutes of Health.

“This neurostimulation is giving the brain a little bit of a boost of its own endogenous opioids to perhaps reduce the need for exogenous morphine, which has all these dangerous side effects when delivered for prolonged periods of time in this critical neurodevelopmental window,” said Bashar Badran, Ph.D., an assistant professor in the College of Medicine Department of Psychiatry and Behavioral Sciences who specializes in brain stimulation.

In the Spark/MUSC NOWS trial, tAN therapy delivers gentle electrical stimulation to cranial nerve branches on and around the newborn’s ear. It is believed that tAN activates specific brain regions to signal the release of endogenous opioids (endorphins), which bind to the vacant opioid receptors and ease the withdrawal symptoms. This study was designed to deliver tAN before each scheduled morphine dose, allowing for the endorphins to supplant the need for morphine. The process effectively reduces total morphine administration and, ultimately, days spent in the NICU.

Clinical results to date:

Since April 2020, three newborns have enrolled in and completed the clinical trial.

From the start of tAN therapy administration, all newborns were safely weaned off morphine within an average of 10 days — faster than the 21-day national average.

“When you see babies who are withdrawing from opioids, you immediately feel terrible for them. They are in a lot of distress. They are jittery, crying constantly, hard to soothe and console, and may have fast breathing and vomiting,” said Dorothea Jenkins, M.D., a professor of pediatrics who specializes in newborns. “This open-label clinical trial is designed to show that a seven- to 10-day morphine wean is safe and achievable with tAN, which would be a significant improvement over standard of care,” Jenkins said. “With three infants successfully completing the protocol, we are encouraged that this therapy may offer benefit.”

Principal Investigator, Dr. Navid Khodaparast, Ph.D., Spark Biomedical’s Chief Science Officer, said, “While we have seen success with tAN™ therapy in our adult opioid withdrawal clinical trial, we weren’t sure how this treatment approach would generalize to newborns with NOWS. Now that the trial is underway, the results are beyond our expectations, and most importantly, have improved the lives of the newborns and their families.”

The MUSC/Spark NOWS clinical trial is funded by a $217,690 SBIR grant from the National Institutes of Health HEAL initiative (1R43DA050360-01).

About Spark Biomedical, Inc.

Spark Biomedical, Inc. is a Texas-based medical device company developing wearable neurostimulation solutions for opioid withdrawal relief. The Spark team is dedicated to helping the world overcome, heal, and achieve through the use of wearable neurostimulation.

About MUSC Children’s Health

MUSC Children’s Health is changing what’s possible for children and their families by providing the pediatric clinical and research expertise every child deserves and needs. From promoting healthy lifestyles to offering life-saving treatments, Children’s Health delivers comprehensive and compassionate care to children throughout South Carolina and beyond.

Our integrated children’s health care system consists of the MUSC Shawn Jenkins Children’s Hospital and Pearl Tourville Women’s Pavilion  l located on the Charleston peninsula, which is one of the most patient- and family-centered and technologically advanced hospitals for children and their families in the United States; the Charles P. Darby Research Institute, where pediatric research teams conduct significant and ongoing efforts; the R. Keith Summey Medical Pavilion in North Charleston, which offers ambulatory care, a surgery center, specialty care, and after-hours clinics; and finally, expanded depth and breadth of expertise in multiple neighborhood locations throughout the Lowcountry, offering primary, urgent and specialty care in person or via telehealth. For more information visit https://musckids.org.

The research reported in this publication is supported by the National Institute on Drug Abuse of the National Institutes of Health under award number 1R43DA050360-01. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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