The safety of BEMA (BioErodible MucoAdhesive) Fentanyl for breakthrough pain (BTP) in cancer patients

Abstract

20586 Background: The BEMA drug delivery system was designed for rapid oral transmucosal drug delivery with dose to dose reliability of plasma concentrations and ease of patient use. BEMA Fentanyl consists of a small, dissolvable, polymer disc formulated with the opioid narcotic fentanyl for application to the buccal membranes. The mucoadhesive polymers adhere and rapidly deliver fentanyl into the bloodstream. Methods: Subjects with cancer-related breakthrough pain (BTP) who were receiving concomitant chronic opioid therapy were enrolled in two studies: a double-blind, randomized, placebo-controlled, multiple crossover study (FEN-201) and an open-label study (FEN-202). In FEN-201, subjects entered a titration period followed by a double-blind period and received BEMA Fentanyl or placebo in random order. In FEN-202, subjects successfully completing FEN-201 and a second group of subjects meeting the same entry criteria as for FEN-201 were enrolled to receive open-label BEMA Fentanyl. Subjects in both studies were titrated to an effective dose (starting at 200μg and increasing to 1200μg in FEN-201 and 2400μg in FEN-202) and then continued with dosage adjustment as required. Results: In FEN-201, 141 subjects received an average of 14 doses of study medication over the course of the study. In FEN-202, a total of 220 subjects (70 from FEN-201 and 150 additional subjects) entered the study and received an average of 2.9 doses/day for 111.9 days (maximum duration of 531 days) in the open-label period. The most commonly reported treatment-related adverse events (AEs) during the titration and double-blind periods of FEN-201 were somnolence (6.0%), nausea (5.3%), dizziness (4.6%), and vomiting (4.0%). In the long-term safety study (FEN-202), these 4 events and constipation were the most commonly reported treatment-related AEs. There were no reports of treatment-related respiratory depression or death in either study. No unexpected findings or adverse trends were noted in vital signs or physical examination findings. Conclusions: BEMA Fentanyl administered in doses of 200 to 2400μg was shown to be safe and well-tolerated with no unexpected safety concerns. The AE profile of BEMA Fentanyl was consistent with the use of an opioid in patients with cancer and chronic pain. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration BioDelivery Sciences International BioDelivery Sciences International BioDelivery Sciences International BioDelivery Sciences International