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This guidance reflects the Agency’s current thinking regarding drug product development and trial design issues relevant to the study of depot buprenorphine products (i.e., modified-release products for injection or implantation) for the treatment of opioid use disorder (OUD). This guidance focuses on the development of depot buprenorphine products for which submission of a new drug application (NDA) through the pathway described in section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) may be appropriate.

For recommendations on specific depot buprenorphine product development programs, sponsors should contact the Division of Anesthesia, Analgesia, and Addiction Products (the Division) in the Center for Drug Evaluation and Research.

Posted on the FDA website on 6 February 2019