Long-term Safety and Efficacy Study of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain

This was an open-label multi-center study of the safety of fentanyl sublingual spray as a treatment for breakthrough cancer pain. The study medication was administered under the tongue as a simple spray and could be self-administered by patients or assisted by their caregivers. In addition to safety, there was a questionnaire to assess satisfaction with the study medication. Subjects could enter this study by 1 of 2 routes: * De novo subjects who meet the inclusion criteria and none of the exclusion criteria at the Screening Visit were enrolled into the Open-label Titration Period of the study. Upon successful completion of the titration period, patients entered the Open-label Maintenance Period. * All patients who successfully completed the Double-blind Randomization Period and the Final Visit of study INS-05-001 (NCT00538850) were eligible to enter the Open-label Maintenance Period of this study.