Date of Award


Degree Type

Selective Evidence-Based Medicine Review

Degree Name

Master of Science in Health Sciences - Physician Assistant

Department Chair

John Cavenagh, PhD, PA-C


OBJECTIVE: The objective of this systematic review is to determine whether fentanyl pectin nasal spray (FPNS) is safe and effective treatment for patients with breakthrough cancer pain.

STUDY DESIGN: Review of three English language primary randomized controlled trials published 2010-2011.

DATA SOURCES: Multicenter, randomized, double-blind, double-dummy, placebo-controlled trials comparing fentanyl pectin nasal spray, immediate-release morphine sulfate, and/or nasal spray placebo were found using PubMed, COCHRANE, and Medline databases.

OUTCOME MEASURED: All three studies essentially used similar parameters to measure effectiveness and safety of fentanyl pectin nasal spray compared to oral immediate-release morphine sulfate and/or placebo. Baseline pain intensity was scored 0-10. Pain intensity (PI) and pain relief (PR) were measured at 5, 10, 15, 30, 45, 60 minutes in order to assess time intervals clinically meaningful pain relief and maximum pain relief has been achieved. Adverse events were also recorded through all phases of the studies, and objective nasal tolerability assessments were performed.

RESULTS: Collectively, the results demonstrated that clinically meaningful pain relief was achieved by fentanyl pectin nasal spray in as early as 10 minutes when compared to the control. Furthermore, approximately half the breakthrough cancer pain episodes achieved maximum pain relief at 60 minutes with FPNS compared to just over one-third of patients with immediate-release morphine sulfate. No significant nasal effects were reported, and there were no nasal tolerability parameters reported at moderate to severe intensity.

CONCLUSION: The three randomized-controlled trials demonstrate that fentanyl pectin nasal spray is both safe and effective for the treatment of BTCP episodes compared to the current gold standard of treatment and placebo. The efforts of the studies used have contributed to the FDA approval of this first intranasal option in 2011 for cancer patients suffering from inadequately managed breakthrough cancer pain.