Exploring ondansetron as potential therapy for opioid-exposed infants (2025)

• Download PDF Copy

Reviewed

As the opioid crisis continues, the number of babies born with neonatal opioid withdrawal syndrome (NOWS) – a condition that affects infants whose mothers used opioids during pregnancy – has risen 5-fold over the past 20 years. According to the Centers for Disease Control (CDC), there are 20,000 infants a year in the United States born with signs of NOWS. These infants often require extended hospital stays and, in some cases, treatment with medications like morphine to relieve withdrawal symptoms.

A new study from Walter Kraft, MD, an internist and clinical pharmacologist at Thomas Jefferson University, and his team further explored the potential of ondansetron, a medication commonly used to treat nausea and considered safe during pregnancy, to help reduce withdrawal symptoms in newborns with NOWS.

The research expands on data from Dr. Kraft's previous work, along with collaborators at Stanford University, of a clinical trial conducted at Jefferson and other sites. That study explored the impact of ondansetron in 90 infants and found that it significantly reduced the severity of withdrawal symptoms.

The current investigation, led by first author Kevin Lam, PharmD, used Bayesian population pharmacokinetic modeling – a mathematical method that describes how different patients process a drug – to identify the concentration of ondansetron that would lead to symptom relief. The model can be used to simulate optimized ondansetron doses.

In the past, we might have used gut intuition and said, 'Let's just double the dose'. Now we can use mathematical modeling to be much more likely to find an effective dose and require fewer patients to enroll in a clinical trial."

Dr. Walter Kraft, MD, internist and clinical pharmacologist at Thomas Jefferson University

Dr. Kraft, who is also a faculty member at Sidney Kimmel Medical College, says his team is seeking funding for future clinical trials to explore whether ondansetron can reduce the number of symptoms experienced by infants with NOWS or shorten their hospital stay.

"This is a complex medical and societal issue. There's unlikely to be a single solution," Dr. Kraft said. "We're optimistic that ondansetron may be part of a multi-pronged approach to improving care for these infants."

• Download PDF Copy