Study to Explore Effectiveness of Sublingual Fentanyl Spray in Emergency Department Patients With Acute Pain

A Randomized, Multicenter, Double-Blind, Double Dummy, Active Comparator, Dose-Ranging Study to Explore the Efficacy of SUBSYS® in Emergency Department Patients With Acute Pain

This study will explore effectiveness of three doses of fentanyl sublingual spray against an active comparator in emergency department (ED) patients with acute pain.

After screening, eligible participants will participate in a treatment period (up to 2 hours) and a post-treatment evaluation period (up to 4 hours or discharge from the ED). Open-label standard of care rescue medication for pain can be given at any time during the study period, based on clinical judgment of the treating physician.

Adverse events will be collected for five days after initial enrollment.

Inclusion Criteria:

• Is able to understand the language in which the study is being conducted and has provided meaningful written informed consent for the study
• Has an acute painful condition requiring parenteral analgesia as deemed necessary by the treating physician or physician extender
• Has a pain score within protocol-specified parameters

Exclusion Criteria:

• Has allergy to fentanyl or morphine
• Has oxygen-dependent conditions or oxygen saturation <95%
• Has planned or recent drug use outside protocol-specified parameters
• Has any condition that, in the principal investigator's opinion, would place the patient at risk or influence the conduct of the study or interpretation of results