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  1. Drug Safety and Availability

FDA recommends changes to labeling for transmucosal buprenorphine products indicated to treat opioid use disorder

Today, FDA issued the Federal Register notice, Modifications to Labeling Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence, to encourage the submission of supplemental new drug applications to modify the labeling statements for buprenorphine-containing transmucosal products for the treatment of opioid dependence (BTODs). 
 
BTODs are medications that are dissolved in the mouth and contain buprenorphine, or a combination of buprenorphine and naloxone, and are indicated to treat opioid use disorder (OUD)—previously referred to as opioid dependence.

FDA has received feedback from multiple interested parties (e.g., health care practitioners, patients, professional societies), indicating a misperception by some that labeling for BTODs includes a maximum daily dose when, in fact, the labeling does not specify a maximum dose. We also received similar feedback through several meetings in which FDA participated, including a two-day public meeting with the Reagan-Udall Foundation for the FDA in May 2023 and two listening sessions led by the Substance Abuse and Mental Health Services Administration (SAMHSA) in November and December 2023. For this reason, FDA is recommending revisions to BTOD labeling to avoid misinterpretation of dosing information. 

“Current BTOD 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, Ph.D., 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.” 

The recommended labeling changes are intended for transmucosal buprenorphine products only, such as Suboxone, Zubsolv, and other generic transmucosal buprenorphine medications. The recommended changes intend to clarify that neither 16 mg/day nor 24 mg/day should be interpreted as maximum dosages for these medications and to provide additional labeling recommendations including:

  • Removing the phrase “target dose” from the labeling; and
  • Modifying the existing 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 for BTODs,” said Yngvild K. Olsen, MD, MPH, director for the Center for Substance Abuse Treatment at 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.” 

Today’s action follows several prior FDA actions regarding buprenorphine and treatment for OUD, including issuing a joint letter with SAMHSA in May 2023 to clarify the importance of counseling and other services as part of a comprehensive treatment plan, as well as reiterating that providing buprenorphine should not be made contingent upon participation in such services; approving a new buprenorphine treatment option for OUD in May 2023; and launching a campaign to inform, encourage, and provide resources to prescribers utilizing medication to treat OUD in May 2024. 

Together, these actions aid in propelling FDA forward in implementing the FDA Overdose Prevention Framework, which provides our vision to undertake impactful, creative actions to encourage harm reduction and innovation in reducing controlled substance-related overdoses and deaths. As we continue executing that vision, we remain focused on responding to all facets of substance use, misuse, overdose, and death through the four priorities of the framework, including: supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks.

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