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

The BEMA^TM drug delivery system was designed to improve oral transmucosal dosing reliability, tolerability, and patient acceptance. The mucoadhesive polymers adhere and deliver fentanyl across the capillary rich mucosa.

Two-hundred twenty (220) adult opioid-tolerant patients with chronic cancer pain who experienced one to four daily episodes of BTP while on stable opioid doses (i.e., a daily dose equal in analgesic activity to at least 60 mg of oral morphine) received BEMA^TM Fentanyl in an open-label, multicenter study. Patients were titrated to an effective dose and then continued with dosage adjustment as required. The initial effective dose was £1200 µg in 94.3% of subjects entering the Open-label Period. Administration of the initial 200 µg dose of BEMA^TM Fentanyl to 97/220 subjects was monitored by study personnel; none of the subjects experienced AEs. Patients received, on average, 2.9 doses per day for 111.9 days (maximum exposure duration of 531 days). The most frequently reported AEs attributed to study drug were nausea (8.6%), dizziness (5.5%), constipation (5.0%), and somnolence (4.5%); these four AEs were also the only AEs that appeared to be dose-related (during the Titration Period only). Although more than 56,000 episodes of BTP were treated with BEMA^TM Fentanyl in this study, only one case of respiratory depression was reported, an event not attributed to study drug. There were no deaths attributed to study drug. There was no relationship between the incidence of AEs and age, gender or race. Three (1.4%) subjects experienced mild stomatitis that was possibly related to BEMA^TM Fentanyl; none resulted in study drug discontinuation. The AE profile of BEMA^TM Fentanyl was consistent with the use of an opioid in patients with cancer and chronic pain.

Research supported by BioDelivery Sciences International