FDA approves Abstral with required REMS enrollment

FDA has approved fentanyl (Abstral, ProStraken) transmucosal tablets to manage breakthrough pain for adults with cancer. Fentanyl immediate-release transmucosal medications are administered on the soft surfaces of the mouth (inside of the cheek, gum, tongue), or the nasal passages or throat where they dissolve and are absorbed.

Abstral is indicated for the management of breakthrough pain in patients with cancers, aged >18 years, who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medication.

Abstral is available only through a Risk Evaluation and Mitigation Strategy (REMS) program, which is intended to minimize the risk of misuse, abuse, addiction, and overdose. Under this program, pharmacies, distributors, and healthcare professionals who prescribe to outpatients are required to enroll in the program to prescribe, dispense, and distribute this product.  

“REMS has become the standard by FDA to allow or speed approvals through their approval system,” said F. Randy Vogenberg, PhD, RPh, strategic pharmacy advisor, Business Group Pharmacy Collaborative, Greenbelt, MD, and senior fellow, Jefferson School of Population Health, Philadelphia. “However, REMS administrative time and costs have become a bigger issue for hospitals as well as clinicians who are not reimbursed for time related to REMS. That indirect economic toll on the healthcare delivery and payer system has effectively blunted much of potentially available clinical benefit for allowing most newer medications on the market.”

Vogenberg added that for the daily growing number of baby boomers who will face cancer, chronic disease, and issues with pain management including end-of-life care, approvals for medications such as Abstral to manage breakthrough pain is increasingly important.

“Still troublesome is the restrictive regulation and attitudes by DEA as well as FDA and many other state law enforcement personnel around pain management,” he said. “While abuses do occur and need to be addressed, improving access to pain management remains one of the greatest unknown needs in healthcare. As this issue becomes more known and commonly seen in our population, new regulations and enforcement plans will have to be developed which will be driven by baby boomers who are used to making change happen in the United States.”