At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Cancer pain or pain from cancer treatment
- ✓Stable chronic opioid therapy: 60–1000 mg/day oral morphine equivalent or 50–300 µg/hr transdermal fentanyl
- ✓Experience 1–4 breakthrough pain episodes per day requiring additional opioids
- ✕ECOG performance status 4 or 5
- ✕Moderate (Grade 3) to severe (Grade 4) mucositis
- ✕Rapidly escalating pain requiring background opioid dose increase during study
- ✕Psychiatric, cognitive, or neurological impairment limiting ability to understand or complete diary
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label, Long-term Treatment Evaluation of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy
In Brief
A Phase 3 clinical trial evaluating BEMA Fentanyl for Pain and Cancer. Completed, enrolled 244 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the safety of BEMA fentanyl at any dose in the management of breakthrough pain in cancer subjects on background opioid therapy. The standard of care for these breakthrough pain episodes is a rapid onset, short acting analgesic with minimal associated sleepiness. Oral morphine, oxycodone and hydromorphone are routinely used, but because of slow and variable oral absorption, the pain control is not the best with these products. Oral transmucosal fentanyl citrate (OTFC) has been used successfully in treating breakthrough pain episodes associated with cancer. OTFC is a lozenge of fentanyl on a stick and is administered by continuously swabbing the interior of the subject's mouth until the product is dissolved (approximately 15 to 30 minutes). The buccal route of administration avoids the delay and variability associated with oral absorption. BioDelivery Sciences International, Inc. (BDSI) has developed BEMA (BioErodible MucoAdhesive) fentanyl, an alternative product to OTFC that does not require the subject to continuously paint the inside of the mouth with the dosage form. The BDSI product is a small disc that is placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the disc readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of the disc are water soluble, so the entire dosage form dissolves within 30 minutes of application.
Study Details
Timeline
Interventions
buccal soluble film; 200, 400, 600, 800, 1200 mcg fentanyl; up to 4 times daily