This is the second cohort in the clinical trial entitled “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,” (NCT06047834). The study is sponsored by USWM, LLC, through a grant from the National Institute on Drug Abuse (NIDA) (# UG3DA054799).
“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, Ph.D., associate director of research in the Division of Addiction Sciences at the Joan C. Edwards School of Medicine. “Currently, the standard of care for NOWS involves opioid medications such as morphine or methadone, which have adverse effects and prolong the withdrawal process. Unlike opioids, lofexidine does not produce euphoria or the potential for addiction, making it a potentially more desirable option for managing withdrawal symptoms. We hope to demonstrate the potential of lofexidine as an alternative for neonates with NOWS.”
The randomized, controlled clinical trial will enroll up to 24 eligible newborns at Hoops Family Children’s Hospital at Cabell Huntington Hospital, a member of Marshall Health Network. Hoops Family Children’s Hospital, a 72-bed children’s hospital within a hospital, houses a Neonatal Therapeutic Unit (NTU), which provides specialized, comprehensive care for infants prenatally exposed to opioids through a multidisciplinary team of physicians, nurses, pharmacists, social workers and support staff.
Hoops is the first hospital in the country to offer this non-opioid investigational treatment option for NOWS. The study will assess the safety and pharmacokinetics of lofexidine, while also evaluating NOWS symptoms using the Modified Finnegan Neonatal Abstinence Scoring Tool (mFNAST), the duration of treatment, need for rescue medication and length of hospital stay.
In previous clinical studies of lofexidine in adults, the most common adverse events were orthostatic hypotension, bradycardia, hypotension, dizziness, somnolence, sedation, and dry mouth.
Enrollment in the clinical trial is ongoing with enrollment targeted to be completed by the end of 2024. Results from this study will be used to support dosing recommendations in neonates and to inform further studies in the pediatric patient population.
For more information about the trial, please visit https://clinicaltrials.gov/study/NCT06047834 or contact Dr. Todd Davies at daviest@marshall.edu.
Study number Pro00068694 has been approved by Advarra Institutional Review Board with local review by the Marshall University Institutional Review Board #1 (Marshall IRB study number 2050154).