FDA Seeks Clearer Labeling for Transmucosal Buprenorphine Product Dosing
To avoid misperceptions that current labeling for buprenorphine-containing transmucosal products includes a maximum daily dose, the US Food and Drug Administration (FDA) is encouraging the submission of supplemental new drug applications to change the labeling statements. The agency recently published its notice, “Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence,” in the Federal Register.
“Current … labeling has been misinterpreted by some as suggesting a maximum dosage of 16 or 24 milligrams (mg) daily although the labeling does not explicitly provide a maximum dosage,” said Marta Sokolowska, PhD, deputy center director for Substance Use and Behavioral Health at the Center for Drug Evaluation and Research. “Our recommendations seek to clarify, via the labeling, that daily maintenance dosages can be incrementally adjusted for each patient based upon their individual therapeutic need and that daily doses higher than 24 mg per day may be appropriate for some patients.”
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The recommendation follows feedback from health care providers, patients, and professional societies regarding a perceived maximum daily dose in patients with opioid use disorder (OUD). The recommended changes, intended for transmucosal buprenorphine products only, aim to clarify that neither 16 mg/day nor 24 mg/day should be interpreted as maximum dosages for Suboxone, Zubsolv, and other generic transmucosal buprenorphine medications, and to provide additional labeling recommendations. They include:
- Removing the phrase “target dose” from the labeling; and
- Changing the statement “Dosages higher than 24 mg daily have not been demonstrated to provide a clinical advantage” to read “Dosages higher than 24 mg buprenorphine daily have not been investigated in randomized clinical trials but may be appropriate for some patients.”
“We stand with FDA’s recommendation to update the labeling,” said Yngvild K. Olsen, MD, MPH, director for the Center for Substance Abuse Treatment at the Substance Abuse and Mental Health Services Administration (SAMHSA). “The role these medications play in saving lives and allowing people with OUD to thrive and achieve well-being is tremendous. Updated labeling will help more practitioners provide transmucosal buprenorphine-containing medications in a person-centered manner that facilitates retention in efficacious treatment.”
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