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