The Food and Drug Administration’s approval of immediate-release Abstral (fentanyl) transmucosal tablets provides a new option for managing breakthrough pain for adults with cancer.
Approved on Jan. 7, the drug is indicated for the management of breakthrough pain in patients aged 18 years and older with cancer, who already use around-the-clock opioid pain medication and who need and are able to safely use high doses of an additional opioid medicine.
Breakthrough pain is defined as pain that comes on suddenly for short periods of time and is not alleviated by a patient’s usual pain management plan. These patients should be considered opioid tolerant because of their current opioid medication use, according to a news release from the agency.
Immediate-release transmucosal medications, such as Abstral, are administered on the soft surfaces of the mouth, the nasal passages or throat where they dissolve and are absorbed.
The approval comes with the condition that the drug only be made available through through a Risk Evaluation and Mitigation Strategy (REMS) program, in order to minimize the risk of misuse, abuse, addiction, and overdose. Fentanyl is a schedule II opioid under the Controlled Substances Act.
The program requires pharmacies, distributors, and health care professionals who prescribe to outpatients to enroll in the program in order to prescribe, dispense, and distribute this product.
Common adverse reactions include nausea, constipation, drowsiness, and headache. Serious adverse events, including deaths, have been reported in patients with other immediate-release transmucosal fentanyl products, according to the FDA. The deaths occurred as a result of improper patient selection and/or improper dosing.
Health care professionals are encouraged to report adverse side effects or medication errors from the use of this drug to the FDA’s MedWatch Adverse Event Reporting program or by calling 800-332-1088.
Abstral is manufacturedby ProStrakan Inc.