Introduction: Transmucosal delivery of fentanyl can provide prompt control of BTP in patients taking stable doses of opioids for chronic pain^1,2. The BEMA^TM drug delivery system was designed to improve transmucosal dosing reliability and patient acceptance. BEMA^TM Fentanyl consists of a small, bioerodible unit that is placed against the oral mucosa. The mucoadhesive polymers adhere to the membrane and deliver fentanyl across the capillary rich mucosa. The entire unit dissolves within about 30 minutes of application.

Methods: Eighty adult cancer patients on stable opioid doses who achieved adequate control of BTP with BEMA^TM Fentanyl (200 to 1200µg) in an open-label titration phase were treated for up to nine BTP episodes with the previously determined BEMA^TM Fentanyl dose (6 episodes) and placebo (3 episodes) in a double-blind random sequence. Subjects recorded pain intensity (PI, 11-point scale) at the time of treatment, and both PI and pain relief (PR; 5-point scale) at 5, 10, 15, 30, 45, and 60 minutes after treatment. The primary outcome measure was sum of PI differences (SPID) at 30 minutes.

Results: A total of 394 BTP episodes were treated with BEMA^TM Fentanyl and 197 with placebo. SPID values for BEMA^TM Fentanyl treated episodes were statistically significantly greater than placebo treated episodes at 15 minutes (12.7±0.88 vs. 10.6±1.06; p=0.047), 30 minutes (49.1±2.40 vs. 39.0±2.95, p=0.004), and through 60 minutes. Mean PI differences and PRs were higher for the BEMA^TM Fentanyl treated episodes at all time points after 5 minutes and were statistically significantly higher beginning at 30 minutes. The percentage of episodes with ≥33% or ≥50% decreases in PI scores were significantly higher and the percentage of episodes treated with rescue medication significantly lower for BEMA^TM Fentanyl compared to placebo.

Conclusion: BEMA^TM Fentanyl provides patients a rapid, effective, and convenient means to control cancer BTP.