AUSTIN, TX—Fentanyl sublingual (SL) spray demonstrated statistically significant improvements in breakthrough cancer pain relief as early as 5 minutes compared with placebo, investigators reported during the American Pain Society’s 30th Annual Scientific Meeting.
The primary endpoint of the randomized, double-blind, placebo-controlled, multicenter Phase 3 study was assessment of summed pain intensity differences (SPID) at 30 minutes post-treatment. “We present pain assessment data for fentanyl SL spray vs. placebo at the 5-minute post-dose time point,” noted Richard L. Rauck, MD, of the Center for Clinical Research, Winston-Salem, NC, and colleagues.
Fentanyl SL spray doses of 100, 200, 400, 600, 800, 1200, or 1600μg were available during titration and double-blind study periods. Of 130 opioid-tolerant patients enrolled in the 21(+5)-day open-label titration period, 96 (73.8%) were randomized and received treatment during the double-blind phase and post treatment pain assessment (intent-to-treat [ITT] population).
Mean age (SD) of the ITT population was 54.1 (11.7) years. At 5-minutes post dose, mean (SD) SPID scores were 40.3 (57.7) for fentanyl SL spray and 32.0 (52.1) for placebo; a significant difference of 8.3 (34.1; P=0.0219). Use of fentanyl SL spray was found to significantly improve mean (SD) total pain relief scores 5-minutes post dose; 8.6 [3.5] vs. placebo 7.6 [3.3]; difference, 1.0 [2.2]; P<0.0001.
Adverse events (AEs) reported most frequently (≥5% of patients) in the titration period included nausea (13.1%), somnolence (8.5%), dizziness (7.7%), vomiting (7.7%), pyrexia (6.2%), diarrhea (5.4%), and peripheral edema (5.4%). In the double-blind period, the most frequently reported AEs were nausea (7.1%), hyperhidrosis (5.1%), and peripheral edema (5.1%). Three deaths were reported (titration period, n=2; double-blind period, n=1), all of which were due to underlying disease progression and considered unrelated to study drug. No unexpected safety issues were reported.
Dr. Rauck et al. conclude that Fentanyl SL spray is a safe and efficacious treatment for breakthrough cancer pain, with an onset as early as 5 minutes post-dose. Financial support for this study was provided by INSYS Therapeutics.