FDA Finalizes Buprenorphine Drug Development Guidance

Regulatory NewsRegulatory News | 06 February 2019 |  By 

The US Food and Drug Administration (FDA) on Wednesday finalized guidance on developing new types of buprenorphine depot products for medication assisted treatment (MAT) for opioid use disorder amid the ongoing opioid epidemic.
Buprenorphine, along with methodone and naltrexone, are the only drugs approved by FDA to treat opioid use disorder.
Buprenorphine MAT works by reducing patients’ withdrawal symptoms and blocking the euphoric effects of other opioid drugs. With the newly finalized guidance, FDA hopes to promote the development of new modified-release buprenorphine products for injection or implantation. Such products would allow for passive compliance by patients and could lead to better outcomes than self-administered MAT products.
“We’re in urgent need of new and better treatment options for opioid use disorder. The guidance we’re finalizing today is one of the many steps we’re taking to help advance the development of new treatments for opioid use disorder, and promote novel formulations or delivery mechanisms of existing drugs to better tailor available medicines to individuals’ needs,” said FDA Commissioner Scott Gottlieb.
Gottlieb also took aim at private insurance companies, who he said often provide “inadequate” coverage for MATs. “Far too few people who are addicted to opioids are offered an adequate chance for treatment that uses medications,” he said. Despite gains made at the state level, Gottlieb also pointed out that many public insurance plans do not cover all FDA-approved addiction treatments.
The newly finalized guidance focuses on the studies needed to support new drug application (NDA) approval of buprenorphine depot products via the 505(b)(2) pathway.
Depending on the features of the product being reviewed, FDA says that buprenorphine depot products could require relative bioavailability pharmacokinetic studies, though in some cases additional safety and efficacy studies may be required.
Products that are similar to an already approved buprenorphine depot product will likely only require relative bioavailability pharmacokinetic studies and may “rely on the agency’s previous findings of safety and/or efficacy” from a similar product.
For products with novel features, such as new dosing intervals, dose ranges, routes of administration, FDA says sponsors may need to conduct efficacy and/or safety studies to support approval.
The guidance also notes that sponsors can seek to use novel efficacy endpoints, such as reduction in cravings or improvement in sleep or mood, in their studies, though sponsors are encouraged to consult with the agency early on if they plan to use such endpoints.
Additionally, FDA says that other endpoints, such as reduction in hospitalizations, emergency department visits, overdose and death “would be highly valuable,” but notes that measuring such outcomes may “require larger trials than those usually conducted for marketing approval.”
The guidance makes several changes from the draft version released last April. Notably, the agency has replaced references to “opioid dependence” with “opioid use disorder,” a term introduced in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
The guidance also specifies that patients with moderate to severe opioid use disorder should be enrolled in clinical trials for buprenorphine depot products and adds a clarification about using cumulative responder curves in the efficacy analysis.
FDA, Guidance, Federal Register Notice


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