From: Buprenorphine Prescribing and Dosing Limits: Evidence and Policy Goals

o Substance Abuse 2023, Vol 44 (1-2) 17023

o David Tyler Coyle, MD, MS1, Stephanie Stewart, MD, MPHS1, Cole Bortz, BA1, Jane Manalo, BS1, Alexis Ritvo, MD, MPH1, and Martin Krsak, MD, MSc1

"In August 2022, 10 state Societies of Addiction Medicine (CA, CO, HI, IL, MA, NY, OR, PA, UT, and WA) submitted a Citizen Petition (CP; included as Supplemental Material) asking the US Food & Drug Administration (FDA) to update the labeling language for buprenorphine products used to treat OUD to provide greater flexibility for providers to exceed current dosing guidance, while remaining on-label. The CP asked FDA to issue a drug safety communication to providers alerting them to the evidence supporting the utility of daily buprenorphine doses >24mg in treating OUD. The CP’s goal is to raise awareness of the benefits of higher dose buprenorphine— including evidence of improved safety compared to full agonist agents and strategies to reduce risk of precipitated withdrawal—to normalize the practice among both practitioners and payors"