Regulatory Focus™ > News Articles > FDA Releases Shared REMS for TIRF Products, Working on Shared REMS for Other Opioids

FDA Releases Shared REMS for TIRF Products, Working on Shared REMS for Other Opioids

Posted 30 December 2011 | By Alexander Gaffney, RAC 

Are class-wide risk evaluation and mitigation strategies (REMS) products the future of risk mitigation?

The US Food and Drug Administration (FDA) moved one step closer to making that a reality by approving a single, shared REMS system on Thursday that applies to all transmucosal immediate-release fentanyl (TIRF) products. The program, dubbed the TIRF REMS Access Program, is designed to limit the drug to appropriate populations and ensure safe usage by patients.

The program will also unify the currently-fragmented REMS systems that exist in the TIRF class of products, which include Abstral, Actiq, Fentora, Lazanda, Onsolis, and Meda B.  

TIRF products contain fentanyl, which is an opioid pain reliever commonly used by patients who have sudden pain that is not managed by the use of other opioid medications.

The program will begin in March of 2012, at which time all users currently being served by TIRF REMS programs will be transferred to the unified system.

The FDA notes that the goal of the program is to ensure that:

  •         prescribing is limited to appropriate patients;
  •         "inappropriate conversion" of fentanyl products does not occur;
  •         exposure of the product is limited to the intended recipient; and
  •         all persons involved in the process of prescribing the drug-the patient, prescriber, and pharmacist-are all properly educated on the risks associated with TIRF products.

FDA hopes that this new, unified REMS system will "reduce the burden on the healthcare system of having separate REMS programs in place for individual TIRF medicines." 

FDA also notes that, "we are continuing work on another class REMS for the class of long-acting and extended-release opioids."

This could make the TIRF REMS Access Program a bell-weather case study for the FDA.


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