Long-term Safety Study of Sublingual Fentanyl Tablets in Cancer Patients

Exclusion Criteria

• •Have previously been exposed to EN3267.
• •Are pregnant or lactating.
• •Have uncontrolled or rapidly escalating pain.
• •Have any clinically significant condition that would, in the investigator's opinion, preclude participation in the study or compromise data collection. These conditions may include cardiopulmonary disease, and/or neurologic/psychologic conditions.
• •Are scheduled to take MAOIs (monoamine oxidase inhibitors) during the study.
• •Are scheduled to receive anti-neoplastic therapy that, in the investigator's opinion, will influence assessment of breakthrough pain.
• •Are scheduled to receive an investigational drug other than EN3267 during the course of the study.
• •Have hypersensitivity, allergy or contraindication to fentanyl.
• •Have significant prior history of substance abuse or alcohol abuse.
• •Would have difficulty complying with the protocol, as assessed by the investigator.
• •Are unable to read, write, or comprehend the English language in order to complete diaries.