Presented at the 2012 AAPM Annual Meeting « Back

Safety and Efficacy of Fentanyl Sublingual Spray in the Treatment of Breakthrough Cancer Pain

Lowell Reynolds, MD, lreynolds@llu.edu¹, Jonathan Geach, MD², Neha Parikh³, Larry Dillaha, MD³, Janet Bull, MD⁴, (1) Loma Linda University Medical Center, Loma Linda, California, (2) Loma Linda University, Loma Linda, California, (3) Insys Therapeutics, Inc., Phoenix, Arizona, (4) Four Seasons, Flat Rock, North Carolina

Introduction: This randomized, double-blind, placebo-controlled, phase 3 study evaluated the safety and efficacy of fentanyl sublingual (SL) spray for treatment of breakthrough cancer pain. Materials and Methods: Fentanyl SL spray (Subsys®) doses of 100, 200, 400, 600, 800, 1200 (2x600), or 1600 (2x800) μg were available during the 21(+5)-day open-label titration and 21(+5)-day double-blind study periods. The primary endpoint was summed pain intensity differences 30 minutes postdose (SPID30). All patients provided written informed consent; this study received approval from an Institutional Review Board. Results: Of 130 opioid-tolerant patients enrolled in the open-label titration period, 98 (75%) were randomized to the double-blind period (mean age, 54.1 y). Median (range) dose of fentanyl SL spray in the double-blind period was 800 (100-1600) μg. Mean (SD) SPID30 scores were 640.3 (458.8) for fentanyl SL spray and 399.6 (391.2) for placebo (difference, 240.7 [362.9]; P<0.0001). Mean total pain relief at 30 minutes was significantly improved (P<0.0001) in patients receiving fentanyl SL spray (78.3 [20.4]) versus placebo (61.0 [20.8]). The most frequently reported (≥5% of patients) adverse events during the titration period were 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 adverse events were nausea (7.1%), hyperhidrosis (5.1%), and peripheral edema (5.1%). Three deaths were reported; none was considered related to study drug. Conclusions: Fentanyl SL Spray was significantly more effective at relieving breakthrough cancer pain compared with placebo. No new safety concerns were identified.

Funding: Technical editorial assistance was provided by Synchrony Medical, LLC, West Chester, PA. Financial support for this study was provided by INSYS Therapeutics, Phoenix, AZ.