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Buprenorphine In Neonatal Abstinence Syndrome., Walter K. Kraft

Department of Pharmacology and Experimental Therapeutics Faculty Papers

Infants exposed in utero to opioids will demonstrate a withdrawal syndrome known as neonatal abstinence syndrome (NAS). Buprenorphine is a long-acting opioid with therapeutic use in medication-assisted treatment of opioid dependency in adults and adolescents. Emerging data from clinical trials and treatment cohorts demonstrate the efficacy and safety of sublingual buprenorphine for those infants with NAS who require pharmacologic treatment. Pharmacometric modeling will assist in defining the exposure-response relationships and facilitate dose optimization.

Revised Dose Schema Of Sublingual Buprenorphine In The Treatment Of The Neonatal Opioid Abstinence Syndrome., Walter K Kraft, Kevin Dysart, Jay S Greenspan, Eric Gibson, Karol Kaltenbach, Michelle E Ehrlich

Department of Pharmacology and Experimental Therapeutics Faculty Papers

AIMS: More than half of infants exposed to opioids in utero develop neonatal abstinence syndrome (NAS) of severity to require pharmacological therapy. Current treatments are associated with prolonged hospitalization. We sought to optimize the dose of sublingual buprenorphine in the treatment of NAS.

DESIGN: Randomized, Phase 1, open-label, active-control clinical trial comparing sublingual buprenorphine to oral morphine.

SETTING: Large, urban, tertiary care hospital.

PARTICIPANTS: Twenty-four term infants requiring pharmacological treatment for NAS.

MEASUREMENTS: Outcomes were neonatal safety, length of treatment and length of hospitalization.

FINDINGS: Sublingual buprenorphine was safe and effective. Infants treated with buprenorphine had a 23-day length of …