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

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

The purpose of this study is to evaluate the long-term safety and effectiveness of EN3267 in treating breakthrough pain episodes in opioid cancer patients who are using stable doses of opioid medication.

This was a Phase 3 non-randomized, open-label, multicentre study designed to evaluate the long-term safety of EN3267 in the treatment of BTcP in opioid-tolerant cancer patients. The study was conducted in 2 parts:

1. A Titration Period during which patients had up to 2 weeks to determine a single, effective dose of study medication (EN3267) for adequate treatment of BTcP, and
2. A maintenance Period of up to 12 months in which episodes of BTcP were treated with study medication.

Inclusion Criteria:

• 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.

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.