A new tablet delivering transmucosal fentanyl has been approved by the FDA. Abstral (manufactured by ProStrakan Inc., based in Bedminster, New Jersey) is indicated for the management of breakthrough pain in cancer patients aged 18 years and older who are already using opioid medications around the clock and who require—and can safely use—additional opioid medicine.
In 311 opioid-tolerant cancer patients with breakthrough pain, common adverse reactions to Abstral included nausea, constipation, drowsiness, and headache. In announcing its approval of the drug, the FDA noted that serious adverse events, including deaths, have been reported in patients using other immediate-release transmucosal fentanyl products, and that the deaths occurred as a result of improper patient selection and/or improper dosing (www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm239490.htm).
To minimize the risk of misuse, abuse, addiction, and overdose, Abstral is available only through a Risk Evaluation and Mitigation Strategy (REMS) program, meaning providers have to enroll in the REMS in order to prescribe, dispense, or distribute the agent. The FDA recommends that Abstral be prescribed only by health care professionals skilled in the administration of Schedule II opioids for pain treatment.