A Multiple-Dose, Non-Randomized, Open-Label, Multicenter Study to Evaluate the Long-Term Safety and Effectiveness of EN3267 in the Treatment of Breakthrough Pain in Cancer Patients
- Males or females 17 years of age or older.
- Stable cancer-related pain.
- Are receiving a stable, fixed-schedule oral opioid regimen equivalent to 60 to 1000
mg of oral morphine per day or transdermal fentanyl therapy equivalent to 50 to 300
µg/h, and are on a stable dose of opioid medication for relief of breakthrough pain.
- Experiencing 1-4 episodes of breakthrough pain per day.
- Meet the criteria defined in the Eastern Cooperative Oncology Group (ECOG)
Performance Status for Grade 0, 1, or 2.
- 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