FDA Standardizes REMS Documents For Certain Fentanyl Products
This article was originally published in The Pink Sheet Daily
Executive Summary
ProStrakan's Abstral is first use of the REMS templates; the agency expects sponsors of similar immediate-release transmucosal products to follow suit and share a REMS implementation system.
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FDA's approval of ProStrakan's Abstral also heralds the first glimpse at a standardized, class-wide Risk Evaluation and Mitigation Strategy for an opioid. The agency cleared Abstral, a transmucosal tablet formulation of fentanyl, on Jan. 7 to manage breakthrough pain for adults with cancer. The approval came with a REMS, and FDA has made clear that some components will be applied for similar products. The agency has created written templates that can be used to write REMS for immediate-release transmucosal fentanyl products. Those cover the fentanyl REMS document, a patient-prescriber agreement and an enrollment form. In addition to providing the document templates, FDA is directing sponsors of the fentanyl products to adopt a shared system for implementing their safety programs. This is the agency's first foray in producing a standardized REMS that would give sponsors more guidance on how to write their strategies and could pave the way for the class-wide REMS for extended-release opioid products that FDA has been working on since 2009 (Also see "Record-Setting REMS: FDA’s Classwide Opioid Program Will Be “Massive”" - Pink Sheet, 16 Feb, 2009.). A key component of the risk management program is to limit outpatient prescribing, dispensing and distribution of the fentanyl medications to those who enroll in the REMS program in order to minimize the risk of misuse, abuse, addiction and overdose of the drugs. A shared system for putting that program in place would cut the workload of pharmacists - a goal they have pushed for during FDA workshops on how to improve the REMS process. FDA's news release on the approval includes a statement from Office of New Drugs Director John Jenkins that it is "a significant step toward reducing the burden on the health care system of implementing REMS programs." Abstral's labeling contains boxed warnings about the potential for abuse and proper selection of patients. -Cathy Dombrowski ([email protected] ) |