Study of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy

Phase 3

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Male or non-pregnant and non-lactating female. A female of child-bearing potential is eligible to participate in this study if she is using an acceptable method of birth control.
18 years or older
Patient must have pain associated with cancer or cancer treatment
Patient must be on a stable current regimen of oral opioids equivalent to 60 - 1000 mg/day of oral morphine or 50 - 300 µg/hr of transdermal fentanyl (e.g. oxycodone 30 mg, methadone 20 mg, and hydromorphone 7.5 mg)
Regularly experience 1 - 4 breakthrough pain episodes per day that require additional opioids for pain control
At least partial relief of breakthrough pain by use of opioid therapy
Subject must be able to self-administer the study medication correctly.
Subject must be willing and able to complete the electronic diary card with each pain episode.
Signed consent must be obtained at screening prior to any procedures being performed.

Exclusion Criteria

Psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary
Cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression
Recent history or current evidence of alcohol or other drug substance (licit or illicit) abuse
Rapidly escalating pain that the investigator believes may require an increase in the dosage of background pain medication during the study
Moderate (Grade 3) to severe (Grade 4) mucositis (subjects with less than moderate mucositis are permitted and must be instructed to not apply the BEMA disc at a site of inflammation)
Strontium 89 therapy within the previous 6 months
Any other therapy prior to the study that the investigator considers could alter pain or the response to pain medication.
Use of an investigational drug within 4 weeks preceding this study • History of hypersensitivity or intolerance to fentanyl
Regularly more than 4 episodes per day
ECOG performance status of 4 or 5
Subject is pregnant, actively trying to become pregnant, breast feeding or not using adequate contraceptive measures

Arm && Interventions

Group	Intervention	Description
1	BEMA Fentanyl	BEMA Fentanyl

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events.	Participants were followed for the duration of the study, an average of 126 days	After the first dose of BEMA Fentanyl, all adverse events were recorded and summarized.

Secondary Outcome Measures