ASAM Applauds FDA Clarification for Buprenorphine Labeling

Rockville, MD (Jan. 9, 2025) – In response to the Food and Drug Administration’s (FDA) Federal Register notice, Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence, and its subsequent clarification letter to prescribing clinicians, Brian Hurley, MD, MBA, FAPA, DFASAM, president of the American Society of Addiction Medicine (ASAM), issued the following statement: 

“ASAM is encouraged by the FDA’s recommendation that products containing transmucosal buprenorphine for the treatment of opioid use disorder (OUD) should have their labels revised to clarify that there is no maximum dose.  

Given the prevalence of high-potency synthetic opioids, treating patients with an effective, appropriate dose of buprenorphine is critical to get them on the path to remission and recovery. The misconception that there is a maximum dose in the labeling is harmful to patients. It can ultimately delay or prevent potentially lifesaving care; we have also seen this limit Medicaid and private insurance coverage for clinically appropriate, higher doses of buprenorphine. 

Further, this important clarification is in alignment with ASAM’s Clinical Considerations: Buprenorphine Treatment of Opioid Use Disorder for Individuals Using High-potency Synthetic Opioids.” 

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About the American Society of Addiction Medicine    

The American Society of Addiction Medicine (ASAM), founded in 1954, is a professional medical society representing over 7,000 physicians, clinicians, and associated professionals in the field of addiction medicine. ASAM is dedicated to increasing access and improving the quality of addiction treatment, educating physicians and the public, supporting research and prevention and promoting the appropriate role of physicians in the care of patients with addiction. For more information, visit www.ASAM.org.