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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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 A maintenance Period of up to 12 months in which episodes of BTcP were treated with study medication.

Official Title
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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

Conditions
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Pain, Cancer

Intervention / Treatment
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* Drug: EN3267


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sublingual fentanyl tablet<br> | Drug: EN3267<br>* EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses<br>* Other names: Fentanyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the Long-term Safety and Effectiveness of EN3267 |  | screening, 2 week titration period and 12 monthly study visits | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EN3267, Breakthrough Pain, Safety Study, Fentanyl Tablets