Dallas, Texas, March 03, 2022 (GLOBE NEWSWIRE) -- Building on Phase I clinical trial success (Jenkins, Khodaparast, et al., 2021), Spark Biomedical, Inc., and The Medical University of South Carolina (MUSC) rejoin forces, along with UT Southwestern Medical Center, to explore the use of the Sparrow Fledgling™ (formerly the Roo) as adjunctive therapy to reduce withdrawal symptoms associated with neonatal opioid withdrawal syndrome (NOWS).
Recently granted Breakthrough Device Designation by the Food and Drug Administration (FDA), the Sparrow Fledgling is a wearable transcutaneous auricular neurostimulation system (tAN®) that targets trigeminal and vagal nerve branches surfacing on and around the ear. The device delivers safe multimodal neurostimulation through the skin, using a proprietary hydrogel technology and stimulation waveform shown to alleviate opioid withdrawal symptoms in adults and infants. The trial's goal is to complete research and collect necessary clinical evidence to file a 510(k) with the FDA for clearance.
"This NIH/NIDA grant is a testament to the nationwide need and value the Sparrow Fledgling therapy will bring to our society. As we raise funds in our Series A, it's comforting to know that the government is confident in the science and solutions that Spark Biomedical is bringing to the world and backs that with financial support," said Daniel Powell, CEO of Spark Biomedical.
In Spark's Phase I NOWS study, tAN therapy was demonstrated to be safe, comforting, and effective at rapidly weaning infants from oral morphine. Compared with the national average of 23 days on oral morphine, Spark's Phase I study delivered promising results of just nine days. A Phase II study that is randomized, double-blind, sham-controlled, and multicentered would further evaluate the treatment effect.
The clinical study, expected to begin in April 2022, will be overseen by Principal Investigator Navid Khodaparast, Ph.D., Spark Biomedical's co-founder and chief science officer. Dr. Khodaparast commented, "As the pandemic has exacerbated the challenges we face in treating mental health and opioid use disorder, we cannot forget about helping the youngest humans on Earth suffering from the opioid epidemic. This clinical trial will evaluate the effectiveness of tAN therapy as an adjunct treatment to oral morphine that could allow for clearance of this device to be used in neonatal intensive care units across the nation."
Dorothea Jenkins, M.D., professor of pediatrics, MUSC Division of Neonatology, stated, "We are excited to collaborate with Spark Biomedical again on the phase II trial. We will be testing a therapy that has the potential to greatly reduce opioid replacement for neonates who have withdrawal symptoms. In conducting the phase I trial, we found the Sparrow Fledgling to be very well-tolerated by babies and well-accepted by their parents as a noninvasive, nonpharmacologic approach to managing the tremors, fever, poor feeding, and inconsolable crying that are characteristic of opioid withdrawal. We look forward to conducting this randomized clinical trial to investigate how well tAN helps manage the difficult symptoms of opioid withdrawal without subjecting the baby to more opioids."
Bashar Badran, Ph.D., neuroscientist and assistant professor, MUSC Department of Psychiatry and Behavioral Sciences, further emphasized, "We are living in an amazing time in technological history. We now have the capability to build safe, non-invasive wearable brain stimulation therapies that have the potential to reduce the societal burden of the opioid crisis in America."
The clinical trial aims to:
- Determine whether tAN therapy can reduce the median number of days of oral morphine treatment after the start of treatment.
- Assess improvement in neurobehavior measured using the Neonatal Intensive Care Unit Network Neurobehavioral Scale.
- Prepare to file a 510(k).
Venkat Kakkilaya, M.D., UT Southwestern Pediatric Group, stated, " This study could also open other targets for use in other neonatal conditions."
NOWS is a condition that causes withdrawal symptoms in infants after in-utero exposure to prescription or nonprescription opioids such as methadone or heroin (Witt et al., 2017). Because of the abrupt termination of opioid delivery to the central nervous system at birth, many infants experience withdrawal symptoms within 48 to 72 hours of birth. Withdrawal symptoms include tremors, high-pitched crying, tachypnea, poor feeding, vomiting, weight loss, mottling, dysregulation of body temperature, and disrupted sleep (Ko et al., 2017; Kraft & van den Anker, 2012; Patrick et al., 2020).
There is currently no nationwide standard of care for NOWS. Oral morphine or methadone are considered first-line therapies, and other medications, including clonidine and phenobarbital, are used as adjuncts when needed. Administering harsh therapies to a newborn is not optimal and can introduce additional stress on the newborn (Hudak et al., 2012). For example, administering morphine during early neurodevelopment may cause neuron cell death, white matter injury, and oxidative stress (Attarian et al., 2014; Flannery et al., 2020; Rao et al., 2007; Steinhorn et al.,2015). Spark's Fledgling device, using tAN therapy, seeks to minimize and/or eliminate those treatment side effects.
About Spark Biomedical
Spark Biomedical, Inc. is a leading U.S.-based wearable neurostimulation solutions developer devoted to the life-saving work of helping 36.3 million people worldwide overcome withdrawal, heal from addiction, and achieve the better quality of life they deserve. With opioid-related misuse and overdose deaths on the rise, the company's mission is to eliminate opioid addiction by working to address the full opioid addiction lifecycle, including withdrawal management, opioid sparing, relapse prevention, and PTSD/trauma abatement.
Spark Biomedical is helping patients take the first step of overcoming acute opioid withdrawal with its FDA-cleared wearable technology, the Sparrow Therapy System — Transcutaneous Auricular Neurostimulation (tAN®) for Opioid Withdrawal Relief. Sparrow Therapy provides an easy, safe, and effective drug-free treatment option supported by clinical evidence. Next steps are underway with the launch of two NIDA-funded clinical trials to improve adult relapse rates and help infants suffering from Neonatal Opioid Withdrawal Syndrome (NOWS).
Learn more at sparkbiomedical.com or on LinkedIn.
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, 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/.
About The Research
The research reported in this publication is supported by the National Institute on Drug Abuse of the National Institutes of Health under award number 2R44DA050360. 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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