A Phase 2 Multicenter, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Placebo-Controlled Study of Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain
Phase: PHASE2
Conditions: Pain
Sponsor: INSYS Therapeutics Inc

CLINICAL TRIAL PROTOCOL 
A Phase 2 Multicenter, Randomized, Double-Blind, Multiple-Dose, 
Parallel-Group, Placebo-Controlled Study of Fentanyl Sublingual Spray 
for the Treatment of Moderate to Severe Post-Operative Pain 
Protocol Number: 
Protocol Amendment l Date: 
Protocol Version: 
Investigational Product: 
IND Number: 
Sponsor: 
Principal Investigator: 
INS002-16-092/ NCT02915978
21 Dec 2016 
2.0 
Fentanyl Sublingual Spray 
121254 
Insys Development Company, Inc. 
1333 South Spectrum Blvd, Suite 100 
Chandler, AZ 85286 
Medical Monitor: 
, MD 
Insys Development Company, Inc. 
 
Phone: 
 
Fax: 
 
Confidentiality Statement 
This study will be performed in compliance with Good Clinical Practices (GCP) and applicable regulatory 
requirements. The confidential information in this document is provided to you as an investigator, 
potential investigator or consultant for review by you, your staff and applicable Independent Ethics 
Committee (IEC) or Institutional Review Board (IRB). It is understood that the information will not be 
disclosed to others without written authorization from Insys Development Company, Inc., except to the 
extent necessary to obtain informed consent from those persons to whom the drug may be administered.