FDA label changes for transmucosal buprenorphine products

The US Food and Drug Administration (FDA) has issued the Federal Register notice, Modifications to Labeling of 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).

The FDA says it has received feedback from multiple interested parties (eg, 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. It has 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 listing sessions led by the Substance Abuse and Mental Health Services Administration (SAMHSA) in November and December 2023. For this reason, the FDA is recommending revisions to BTOD labeling to avoid misinterpretation of dosing information.

This latest action follows several prior FDA actions regarding buprenorphine and treatment for opioid use disorder (OUD, including issuing a joint letter with Substance Abuse and Mental Health Services Administration (SAMHSA) in May 2023 to clarify the importance of counselling) 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.