Study of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy

Inclusion Criteria: Male or non-pregnant and non-lactating female. A female of child-bearing potential is eligible to participate in this study if she is using an acceptable method of birth control. 18 years or older Patient must have pain associated with cancer or cancer treatment Patient must be on a stable current regimen of oral opioids equivalent to 60 - 1000 mg/day of oral morphine or 50 - 300 µg/hr of transdermal fentanyl (e.g. oxycodone 30 mg, methadone 20 mg, and hydromorphone 7.5 mg) Regularly experience 1 - 4 breakthrough pain episodes per day that require additional opioids for pain control At least partial relief of breakthrough pain by use of opioid therapy Subject must be able to self-administer the study medication correctly. Subject must be willing and able to complete the electronic diary card with each pain episode. Signed consent must be obtained at screening prior to any procedures being performed. Exclusion Criteria: Psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary Cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression Recent history or current evidence of alcohol or other drug substance (licit or illicit) abuse Rapidly escalating pain that the investigator believes may require an increase in the dosage of background pain medication during the study Moderate (Grade 3) to severe (Grade 4) mucositis (subjects with less than moderate mucositis are permitted and must be instructed to not apply the BEMA disc at a site of inflammation) Strontium 89 therapy within the previous 6 months Any other therapy prior to the study that the investigator considers could alter pain or the response to pain medication. Use of an investigational drug within 4 weeks preceding this study • History of hypersensitivity or intolerance to fentanyl Regularly more than 4 episodes per day ECOG performance status of 4 or 5 Subject is pregnant, actively trying to become pregnant, breast feeding or not using adequate contraceptive measures