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# FDA Guide on Developing Buprenorphine Depot Products
- URL: https://www.fdaweb.com/fda-guide-on-developing-buprenorphine-depot-products/
- Published: 2019-02-06T12:00:00.000Z
- Updated: 2026-09-15T01:01:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143307

FDA has issued a [final guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM605227.pdf?ref=fdaweb.com) entitled “Opioid Use Disorder (OUD): Developing Buprenorphine Depot Products for Treatment,” which outlines the agency’s current thinking about drug development and trial design issues for such products, such as modified-release formulations for injection or implantation. “When combined with the right treatments and supports, novel formulations or delivery mechanisms described in the FDA guidance – including passive-compliance formulations such as sustained-release depots and implants – can provide effective treatment of OUD, and may result in less misuse, abuse, or accidental exposure compared to self-administered formulations such as transmucosal tablets and films,” the agency says. “This guidance outlines ways that companies can more efficiently advance innovations in buprenorphine depot products – from the data needed to support approval, to the specific review pathways that are available to help streamline how sponsors consider their development plans.”

The document discusses recommended studies for buprenorphine depot products. It also includes information on efficacy studies and trial designs, recommended efficacy endpoints, and novel efficacy endpoints related to buprenorphine. Additionally, it describes circumstances in which an application could be submitted under the 505(b)(2) streamlined pathway.