The FDA recently released Opioid Dependence: Developing Depot Buprenorphine Products for Treatment Guidance for Industry, a draft guidance intended to aid drug developers in the creation and approval of new buprenorphine products aimed at treating opioid use disorder (OUD).
The release of this document hopes to accelerate the development of buprenorphine products that can treat OUD by reducing opioid euphoria, relieving cravings, and normalizing body functions. Buprenorphine, a drug proven to help treat OUD, is currently available in various formulations, and this guidance document explains the FDA’s current thoughts on clinical trial design issues relevant to the study of sustained-release depot buprenorphine products.
The guidance outlines possible ways companies can more efficiently explore innovations in buprenorphine products, including:
- Data needed to support approval
- Specific review pathways to help streamline how sponsors consider development plans
- The types of studies the FDA recommends for depot buprenorphine products
- Depot buprenorphine products with novel features relative to approved depot products
- Information on efficacy studies including trial design
- Recommended efficacy endpoints
- Novel efficacy endpoints related to buprenorphine
The FDA specifically focused on depot formulations of buprenorphine as they believe such formulations may result in less misuse, abuse, diversion, or accidental exposure compared to self-administered formulations such as transmucosal tablets and films, which are absorbed through mucus membranes.
For more information, read the FDA press release.