In March, the Food and Drug Administration plans to deploy a single, shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products.


TIRF REMS Access Program, transmucosal immediate-release fentanyl, TIRF products, Risk Evaluation and Mitigation Strategy,REMS Food and Drug Administration, FDA, Janet Woodcock, Center for Drug Evaluation and Research, opiod, narcotic, Abstral, Onsolis, Actiq, Fentora, Lazanda, breakthrough cancer pain, ProStrakan, Anthony Oladipo, BioDelivery Sciences International, BDSI, Mark Sirgo, Meda Pharmaceuticals




























































































































































































































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FDA to launch single REMS for TIRF products

January 4th, 2012

SILVER SPRING, Md. – In March, the Food and Drug Administration plans to deploy a single, shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products.

The FDA said the new shared system, called the TIRF REMS Access Program, will replace the individual REMS and enable prescribers and pharmacies to enroll into just one system, easing the burden on the health care system.

TIRF medicines are narcotic drugs for managing pain in adults with cancer who routinely take other opioid pain medicines around-the-clock. Brand names of TIRF medications include Abstral, Actiq, Fentora, Lazanda and Onsolis.

According to the FDA, the TIRF REMS Access Program, which was approved late last week, will be used by all sponsors of TIRF products. Until its launch in March, prescribers, patients and pharmacies should continue to enroll in the individual REMS programs, the agency said.

Several TIRF products already have an individual REMS in place. Prescribers and pharmacies enrolled in an individual REMS program for at least one TIRF medicine will automatically be transitioned to the shared TIRF REMS Access Program, the FDA said. Health care professionals who prescribe TIRF medicines that will only be used in an inpatient setting (hospitals, hospice, or long-term care facilities) won't be required to enroll in the program, nor will patients in those settings. Long-term care and hospice patients who get their medications from outpatient pharmacies must still be enrolled.

"This TIRF REMS will ensure safe use and access to these drugs for patients who need them," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement. "We have worked with the sponsors of both the innovator and generic drugs to develop this single, shared system that will streamline the process and decrease the burden of the REMS on the health care system."

The goals of the TIRF REMS Access Program, the FDA said, are to ensure patient access to important medications and reduce the risk of misuse, abuse, addiction, overdose and serious complications due to medication errors by prescribing and dispensing TIRF medicines only to appropriate patients, including use only in opioid-tolerant patients; preventing inappropriate conversion between fentanyl products; preventing accidental exposure to children and others for whom TIRF medicines weren't prescribed; educating prescribers, pharmacists and patients about the potential for misuse, abuse, addiction and overdose.

Makers of TIRF products applauded the FDA's approval of the single REMS program.

"ProStrakan is thrilled to see our hard work and the work of the industry working group culminate in this approval. We are fully committed to patient safety and pleased to help the FDA achieve its goal of assuring appropriate use of pain medications," stated Anthony Oladipo, vice president and global head of drug safety and risk management at ProStrakan Inc., whose Abstral rapidly-disintegrating tablet for breakthrough cancer pain gained FDA approval last January.

"Abstral provides a simple, patient-friendly and efficacious treatment option for cancer patients with breakthrough pain, which can be incapacitating, limiting patients' ability to participate in daily activities," commented John Higgins, general manager at ProStrakan. "Now all TIRF products will be administered equally through a single REMS, making the process simpler for prescribers, patients, pharmacists and distributors."

BioDelivery Sciences International (BDSI) noted that the single TIRF REMS program ends the disparity in prescribing requirements for its product Onsolis (fentanyl buccal soluble film), commercialized in the U.S. by Meda Pharmaceuticals, versus other similar products.

"BDSI was the first company required by the FDA to have a REMS program for a transmucosal fentanyl product. Unfortunately, companies with similar products being marketed prior to the approval of Onsolis were not all held to the same standard. This resulted in a significant commercial disadvantage for Onsolis given the requirements of the REMS and the associated additional steps required by healthcare providers and their patients," stated Mark Sirgo, president and chief executive officer of BDSI.

"We are very pleased to see the approval of a classwide REMS program, which we believe will not only mean a level competitive environment but also the potential for expanded access to Onsolis through availability in retail pharmacies," Sirgo added. "With the implementation of a classwide REMS program late in the first quarter of 2012 by Meda Pharmaceuticals, Onsolis can finally compete on its own merits."

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