Study of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects

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 experiences 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
• Eastern Cooperative Oncology Group (ECOG) performance status of 4 or 5
• Subject is pregnant, actively trying to become pregnant, breast feeding or not using adequate contraceptive measures