The US Food and Drug Administration has approved a fentynal immediate-release transmucosal tablet (Abstral, ProStraken) for breakthrough cancer pain in adults, making it the only fast-acting lingual tablet on the US market. The tablet is indicated for those patients who already use opioid pain medication and can safely use high doses of an additional opioid medication.
This schedule II opioid is available only through a Risk Evaluation and Mitigation Strategies (REMS) program. The manufacturer’s REMS program will allow prescriptions to be filled at retail pharmacies and access to be available in the hospital setting.
Approval of the transmucosal form of the drug (fentyl buccal tablets and patches are already approved) was based on data from safety studies. Based on data from 311 opioid-tolerant patients with breakthrough pain, common adverse reactions included nausea, constipation, drowsiness, and headache. Serious adverse reactions have been previously reported in patients on other immediate-release transmucosal fentanyl products; however, deaths have been attributed to improper patient selection and/or improper dosing.