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FDA Assesses Transmucosal Immediate-Release Fentanyl Products

August 1, 2018
Agency is reviewing risk management strategy for the breakthrough medication

A PPM Brief

FDA Commissioner Scott Gottlieb, MD, issued a statement August 1 regarding the agency’s recent Risk Evaluation and Mitigation Strategy (REMS) assessment of transmucosal immediate-release fentanyl (TIRF) products, large indicated to manage breakthrough pain. As part of an August 3 meeting, an FDA advisory committee will be reviewing findings from the assessments conducted by manufacturers of these products, as well as additional data about their use patterns and adverse events, according to an agency release.

By seeking data on the effectiveness of the REMS and whether changes may be needed, Dr. Gottlieb said the agency is continuing its work to combat the opioid epidemic in the US. “We are committed to striking a careful balance between access and safety, based on reliable evidence,” he said, noting that, “REMS are an important tool for helping to ensure safe use and reduce the risk of abuse and misuse.”

The TIRF REMS went into effect in 2011 to ensure that TIRF products are prescribed only to appropriate patients, including limiting use in opioid-tolerant patients; avoiding avoid inappropriate conversion between TIRF medicines; reducing reduce accidental exposure; and educating the healthcare community about the potential for misuse, abuse, addiction, and overdose.

Since implementation, Dr. Gottlieb noted in his statement that “there has been a significant decline in prescribing of TIRF products and currently they are only prescribed to approximately 5,000 patients nationwide.”

The outside advisory committee experts will address how the TIRF REMS has further affected the prescribing patterns for TIRF products, and how the program might better promote safe prescribing. For instance, said Dr. Gottlieb, “The assessments show that approximately 42% of TIRF products may have been prescribed to non-opioid-tolerant patients. Understanding the reasons for this, whether these patients are truly opioid-non-tolerant, and the range of outcomes for these patients will be a central focus of our public meeting.”

 Added Dr. Gottlieb, “We’re seeking expert input into whether the TIRF products are helping patients who most need these products, as well as whether there are adverse outcomes associated with the current prescribing patterns…. These products can fill an important medical need for a small and carefully selected group of patients. But these products have significant risks associated with their use and should not be used in non-opioid-tolerant patients.”

PPM will report on the outcome of the advisory meeting. Please also see our new special report: Fentanyl: Separating Fact from Fiction by Bettinger, Trotta, Fudin, et al.

Last updated on: August 2, 2018
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