Efficacy and Safety of Sublingual Fentanyl Tablets in Treatment of Breakthrough Pain in Cancer Patients.

Exclusion Criteria

• •Are pregnant or lactating.
• •Have uncontrolled or rapidly escalating pain.
• •Have moderate to severe ulcerative mucositis.
• •Have a cardiopulmonary disease that would increase the risk of administering potent opioids.
• •Have neurologic or psychologic disease that would compromise data collection
• •Have any clinically significant condition that would, in the investigator's opinion, preclude study participation.
• •Are currently taking monoamine oxidase inhibitors (MAOIs), or have taken MAOIs within 14 days prior to enrolling in the study.
• •Have received strontium 89 therapy within 60 days prior to entering the study.
• •Have received anti-neoplastic therapy within 2 weeks of study entry that, in the investigator's opinion, will influence assessment of breakthrough pain
• •Have received any investigational drug (non-approved) within 30 days prior to the first dose of study medication, or are scheduled to receive an investigational drug other than EN3267 during the course of the study.
• •Have hypersensitivities, allergies, or contraindications to fentanyl.
• •Have a significant prior history of substance abuse or alcohol abuse.
• •May have difficulty complying with the protocol, as assessed by the investigator.