The FDA this week published a finalized guidance document for companies developing new buprenorphine depot products for the treatment of opioid use disorder.
The agency is hoping to boost the development of modified-release buprenorphine products, like drug-eluting implants. In the document, the FDA detailed the studies needed to support approval for these products through the 505(b)(2) pathway.
Products that are similar to already-approved buprenorphine depots will only need relative bioavailability pharmacokinetic studies, the FDA wrote. Products with new features – such as new routes of administration – may necessitate additional efficacy and safety studies.
The FDA’s finalized guidance also points out that sponsors can look to use a variety of efficacy endpoints, including improvement in sleep or mood. If a sponsor wants to use a novel efficacy endpoint, the company needs to provide data demonstrating the ability of the endpoint to show a clinically meaningful benefit and the company should consult with the agency early on the drug development process, according to the FDA.
“There is great public health interest in assessing additional, clinically meaningful endpoints such as reduction in hospitalizations, emergency department visits, overdose, and death, as well as improvements in the ability to resume work, school, or other productive activity,” the FDA added.
“Though understanding these outcomes would be highly valuable, the Agency recognizes that evaluating these outcomes could require larger trials than those usually conducted for marketing approval. However, use of such endpoints could provide the basis for additional claims for approved buprenorphine products.”