Prapela

The Opioid Crisis Has Two Patients. A New Trial Reminds Us We Can't Treat One and Call It Done.

New research published in JAMA Internal Medicine deserves attention from everyone working to protect mothers and newborns affected by the opioid epidemic. (https://lnkd.in/eH94DSfd)

Dr. T. John Winhusen and colleagues at the University of Cincinnati, supported by the NIH HEAL Initiative and The National Institute on Drug Abuse - NIDA Clinical Trials Network, completed the first-ever randomized clinical trial comparing extended-release buprenorphine to sublingual buprenorphine for pregnant individuals with opioid use disorder.

The findings for mothers are encouraging: extended-release buprenorphine produced significantly higher illicit opioid abstinence rates during pregnancy (82.5% vs. 72.6%). Mothers who are more stable are better positioned to care for and bond with their newborns.

But for the newborns themselves, the picture was unchanged.

Infants exposed to extended-release buprenorphine showed no reduction in the need for opioid treatment for NOWS compared to sublingual buprenorphine. Treatment duration, peak withdrawal scores, and hospital length of stay were all statistically similar.

This confirms what the broader literature has long shown: no pharmacological treatment given to mothers during pregnancy has been shown to prevent NOWS in newborns.

The biology of withdrawal must still be addressed for each infant after birth. That is precisely what Prapela was designed and authorized to do.

Prapela provides the only FDA-authorized treatment, pharmacological or non-pharmacological, specifically indicated for opioid-exposed newborns. Authorized via the FDA's De Novo pathway and supported by a multicenter RCT published in JAMA Pediatrics, the Prapela SVS Hospital Bassinet Pad delivers continuous therapy around the clock, even when a mother or nurse is not present.

Better maternal treatment is a critical part of solving this crisis. But the newborns still need us.

Great news for newborns and their caregivers! Special thanks to David Morrill and everyone at Saunders Electronics!

Big thanks to Dr. Rachana Singh at Tufts Medical Center and WCVB Channel 5 Boston for this story on our work to help newborns breathe!

Tufts tests tactile mattress to help preemies restart breathing A Tufts trial tests a vibrating mattress that gently stimulates extremely preterm infants.