On February 13, 2019, FDA issued final guidance on developing depot buprenorphine products for treatment of opioid use disorder. FDA new guidance focuses on drug product development and trial design issues relevant to the study of depot buprenorphine products for which submission of a new drug application (NDA) under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) may be appropriate.
Applications for a depot buprenorphine product can be submitted either through an abbreviated new drug application (ANDA) under section 505(j) of the FD&C Act or through an NDA under section 505(b)(2) of the FD&C Act. The regulatory pathway of a new depot buprenorphine product is determined by the characteristics of the investigational product relative to an approved buprenorphine product.
Depot buprenorphine products that are similar to an approved depot product may be submitted under an NDA but may not require efficacy trials. The sponsor may be able to rely on the FDA's previous findings of efficacy and safety for an approved depot buprenorphine formulation using relative bioavailability and pharmacokinetic studies. Parameters used to determine whether a sponsor needs to conduct efficacy trials can be found in the guidance.
Depot buprenorphine products with novel features relative to approved depot products may be submitted under an NDA but may require efficacy and/or safety studies. The guidance provides details on such a development program and design of efficacy trials for these more novel depot buprenorphine products.
Readers are encouraged to read the final guidance also available on FDA's website.
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