A clinical trial evaluating the safety and efficacy of oral lofexidine for newborns with Neonatal Opioid Withdrawal Syndrome (NOWS) has commenced at the Marshall University Joan C. Edwards School of Medicine and Marshall Health Network. This Phase 2 trial, sponsored by USWM, LLC, with funding from the National Institute on Drug Abuse (NIDA), marks a significant step toward providing a non-opioid treatment option for this vulnerable population.
The study, titled “Lofexidine Granules for Reconstitution USWM-LX2-2001 a Phase 2, Open-Label, Randomized, Controlled, Dose Cohort, Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids,” aims to enroll up to 24 newborns at Hoops Family Children’s Hospital. The primary objective is to assess the safety and pharmacokinetics of lofexidine in this population.
Potential Benefits of Lofexidine
“This is a unique study as it aims to provide a non-opioid option to treat neonates prenatally exposed to opioids,” said Principal Investigator Todd Davies, PhD, associate director of research in the Division of Addiction Sciences at the Joan C. Edwards School of Medicine. Current standard of care involves opioid medications like morphine or methadone, which can have adverse effects and prolong the withdrawal process. Lofexidine, conversely, does not produce euphoria or the potential for addiction, making it a potentially more desirable option for managing withdrawal symptoms.
Trial Design and Endpoints
The randomized, controlled trial will monitor NOWS symptoms using the Modified Finnegan Neonatal Abstinence Scoring Tool (mFNAST). Researchers will also track the duration of treatment, the need for rescue medication, and the length of hospital stay. Hoops Family Children’s Hospital houses a Neonatal Therapeutic Unit (NTU) that provides specialized care for infants prenatally exposed to opioids.
Previous Lofexidine Studies
Prior clinical studies of lofexidine in adults have reported adverse events such as orthostatic hypotension, bradycardia, hypotension, dizziness, somnolence, sedation, and dry mouth. The trial aims to establish dosing recommendations for neonates and inform future studies in the pediatric population.
Enrollment is ongoing and is expected to be completed by the end of 2024. The study has been approved by the Advarra Institutional Review Board and the Marshall University Institutional Review Board.
