A Dose Titration Study of Fentanyl Buccal Soluble Film for Breakthrough Cancer Pain in Taiwan

Inclusion Criteria: * a. a stable current regimen of oral opioids equivalent to 60-1000 mg/day of oral morphine or 20-120 mg/day of iv morphine or 25-300 mcg/hr of transdermal fentanyl for one week or longer; * b. regularly experienced 1 to 3 breakthrough pain episodes per day that required additional opioids from pain control; * c. at least partial relief of breakthrough pain by use of opioid therapy; * d. 20 years of age or older; * e. ability to understand and willingness to sign a written informed consent document; * f. able to self-administer the study medication correctly or has the availability of a responsible adult caregiver available to administer the study medication correctly; * g. willing and able to complete patient diary with each pain episode Exclusion Criteria: * a. rapidly escalating pain (e.g., regularly more than 3 breakthrough pain episodes per day) that are hard to be controlled by analgesics; * b. history of hypersensitivity or intolerance to fentanyl; * c. cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression; * d. psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary; * e. moderate (Grade 3) to severe (Grade 4) mucositis (subjects with less than moderate mucositis are permitted and must be instructed to not apply the Painkyl® film at a site of inflammation); * f. abnormal oral mucosa which will impede drug absorption; * g. currently under other treatments that may alter effect of pain control based on investigator's judgment; * h. recent history or current evidence of alcohol or other drug substance (licit or illicit) abuse; * i. use of an investigational drug within 4 weeks preceding this study; * j. pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential;